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December 2020 • Issue #522 AMSTATNEWS The Membership Magazine of the American Statistical Association • http://magazine.amstat.org MY ® STORY ALSO: NC Chapter Offers Tips for Holding a Virtual Career Fair IMSI: A New NSF-Funded Institute
Seattle Statistics, Data, and the Stories They Tell Be on the Program! Key Dates for Participants Key Dates for Attendees January 15, 2021 May 3, 2021 Computer Technology Workshop Registration and Housing Open Proposal Deadline (11:00 a.m. ET) February 22 – April 1, 2021 June 1, 2021 Meeting and Event Request Submission Early Registration Deadline March 16 – April 14, 2021 June 30, 2021 General Abstract Submission Regular Registration Deadline February 3 – April 15, 2021 July 1, 2021 Late-Breaking Session Proposal Submission Housing Deadline July 1, 2021 Draft Manuscript Deadline August 7–12, 2021 Washington State Convention Center ww2.amstat.org/meetings/ jsm/2021
AMSTAT NEWS DECEMBER 2020 • ISSUE #522 Executive Director Ron Wasserstein: ron@amstat.org Associate Executive Director and Director of Operations Stephen Porzio: steve@amstat.org features Senior Advisor for Statistics Communication and Media Innovation 3 What a Year It Has Been! Regina Nuzzo: regina@amstat.org 5 ASA/AAAS Mass Media Fellowship Applications Open Director of Science Policy Steve Pierson: pierson@amstat.org 5 Nominate a Colleague for ASA Director of Strategic Initiatives and Outreach Leadership Position Donna LaLonde: donnal@amstat.org 6 CHANCE Highlights: Special Issue Director of Education Illustrates Importance of Data Privacy Rebecca Nichols: rebecca@amstat.org 7 Giving Day 2020 Raises Nearly $69,000 Managing Editor Megan Murphy: megan@amstat.org 7 Nominations Sought for JABES Editor Editor and Content Strategist 8 An Interview with Margaret Gamalo, Val Nirala: val@amstat.org Editor of JBS Production Coordinators/Graphic Designers 14 IMSI: A New NSF-Funded Institute Olivia Brown: olivia@amstat.org Megan Ruyle: meg@amstat.org 16 My ASA Story Advertising Manager 20 UNC Biostatistics Program Offers Undergraduate Claudine Donovan: claudine@amstat.org Students Opportunity Contributing Staff Members 22 A Conversation with DataKind’s Executive Director, Kim Gilliam • Naomi Friedman • Amanda Malloy Jake Porway Amstat News welcomes news items and letters from readers on matters of interest to the association and the profession. Address correspondence to 23 ASA Journal Gets New Name, Mission Managing Editor, Amstat News, American Statistical Association, 732 North Washington Street, Alexandria VA 22314-1943 USA, or email amstat@ 24 NC Chapter Offers Tips for Holding a Virtual Career Fair amstat.org. Items must be received by the first day of the preceding month to ensure appearance in the next issue (for example, June 1 for the July issue). 25 Virtual StatFest Welcomes International Students Material can be sent as a Microsoft Word document, PDF, or within an email. Articles will be edited for space. Accompanying artwork will be accepted in graphics file formats only (.jpg, etc.), minimum 300 dpi. No material in columns WordPerfect will be accepted. Amstat News (ISSN 0163-9617) is published monthly by the American Statistical Association, 732 North Washington Street, Alexandria VA 22314- 1943 USA. Periodicals postage paid at Alexandria, Virginia, and additional mailing offices. POSTMASTER: Send address changes to Amstat News, 732 North Washington Street, Alexandria VA 22314-1943 USA. Send Canadian address changes to APC, PO Box 503, RPO West Beaver Creek, Rich Hill, 26 STATS4GOOD ON L4B 4R6. Annual subscriptions are $50 per year for nonmembers. Amstat A Look at How Statistical Science Is Making News is the member publication of the ASA. For annual membership rates, see www.amstat.org/join or contact ASA Member Services at (888) 231-3473. an Impact on Poverty American Statistical Association This column is written for those interested in learning about the world of Data 732 North Washington Street for Good, where statistical analysis is dedicated to good causes that benefit our Alexandria, VA 22314–1943 USA lives, our communities, and our world. If you would like to know more or have (703) 684–1221 ideas for articles, contact David Corliss at davidjcorliss@peace-work.org. ASA GENERAL: asainfo@amstat.org ADDRESS CHANGES: addresschange@amstat.org 28 MASTER’S NOTEBOOK AMSTAT EDITORIAL: amstat@amstat.org To Get a PhD or Not to Get a PhD? Part 3 ADVERTISING: advertise@amstat.org WEBSITE: http://magazine.amstat.org This column is written for statisticians with master’s degrees and highlights areas Printed in USA © 2020 of employment that will benefit statisticians at the master’s level. Comments American Statistical Association and suggestions should be sent to Megan Murphy, Amstat News managing editor, at megan@amstat.org. 29 STATtr@k Students Share Virtual Experiences, Tips for Handling Pandemic ® STATtr@k is a column in Amstat News and a website geared toward people The American Statistical Association is the world’s largest who are in a statistics program, recently graduated from a statistics program, community of statisticians. The ASA supports excellence in or recently entered the job world. To read more articles like this one, visit the the development, application, and dissemination of statistical website at http://stattrak.amstat.org. If you have suggestions for future articles, science through meetings, publications, membership services, or would like to submit an article, please email Megan Murphy, Amstat News education, accreditation, and advocacy. Our members serve in managing editor, at megan@amstat.org. industry, government, and academia in more than 90 countries, advancing research and promoting sound statistical practice to inform public policy and improve human welfare.
Happy Holidays departments All of us at the ASA join in wishing you a wonderful 30 meetings holiday season and prosperous, healthy New Year! Virtual WSDS Maintains Connection Among Participants JSM 2021: Opportunities for Involvement Abound INSIDE Look for your 2021 calendar in the center of this issue. MY STORY 34 education 2021 Internships 2 02 1 ® CALENDAR KEY 2021 DATE S NOTABLE EVENTS ES ASA OFFICE CLOSUR JUNE submission deadline February K–12 Project Competition MARCH deadline 1 deadline January 1 New Year’s Day Black History Month DIEGO, JANUARY020, SAN ASA Fellows nomination Links Lecture Award Luther King Jr. Day STORY 1 January 18 Martin March and Fund uted, roundtable, Scholarship Trust Missouri JSM 2021 topic-contrib Edward C. Bryant SDSS 2021, St. Louis, Month 6 submission opens Day Women’s History February 15 Presidents’ application deadline 2–5 invited poster abstract open registration and housing Reporting Award New Orleans, Louisiana SDSS 2021 early Excellence in Statistical 14–17 ICES VI, Day April 14 May 31 Memorial Statistics JSM 2021 computer technology workshop nomination deadline registration and housing open ce Day (Observed) Mathematics and 15 Mentoring Award nomination deadline 15 BIOP 2021 early July 5 Independen Awareness Month (US) proposal deadline oral abstract Application Award CSP 2022 concurrent September 6 Labor Day – October 15 Gottfried E. Noether awards nomination Outstanding Statistical September 15 MY submission deadline Thanksgiving Awareness Month deadline deadline nomination deadline November 25 Hispanic Heritage Academy Award among Academe, Fall Holiday November 26 Partnerships COPSS Leadership November 27 Statistical (SPAIG) Award and roundtable abstract Industry, and Government JULY this date in 1839 BIOP 2021 poster Christmas Day (Observed) December 24 ASA founded on opens 21 nomination deadline abstract submission submission opens 10 SDSS 2021 lightning abstract submission 8 CSP 2022 poster HIA, December 31 New Year’s Day (Observed) ® AUGUST 2020, PHILADELP deadline FEBRUARY ASA Founders Award nomination deadline Data for Good opens Washington ISS 15 abstract submission JSM 2021, Seattle, DAVID CORL Award SDSS 2021 lightning Section Scholarship 7–12 1 Biopharmaceutical for Outstanding Statistical registration opens Karl E. Peace Award WSDS 2021 regular MEETINGS MY Society application deadline the Betterment of opens 14 deadline Contributions for abstract submission CSP 2022 poster abstract submission JSM 2021 contributed 19 Section nomination deadline 16 Education Award Biopharmaceutical BIOP: ASA y has been filled and JSM 2021 topic-contrib uted, roundtable, Causality in Statistics a Workshop launchStatistics d to-Industry submission deadline nomination deadline SEPTEMBERStatistics Section Achievement we’re thrille 2 My ASA stor Regulatory invited poster abstract story, which is why CSP: abstract submission inspirede byal their tions with so and housing open BIOP 2021 roundtable Health Policy on Statistical Practice ICES VI early registration 30 15 loves a good deadline . BeConferenc share theirsICES Everyone ent Statistics with collabora talented, and 10 Awards nomination Conference on Establishm panel, and poster deadline WSDS 2021 concurrent, ASA memb 2021, ers who the personalMeetings VI: Internation and 11 abstract submission opens 21–23featur ingWorkshop connections, JSM:andJoint ul, many wonderf cated to Biopharm series ingful Statistical ASA. 15 W. J. Dixon Award for Excellence in Statistical deadline APRIL submission deadline exper e JSM iences, meancourse Bethesda, Maryland engagSDSS: t with the emenSymposium & Statistics Consulting nomination K–12 Poster Competition divers 2022 continuing education d from their proposal on Data Science ple dedi ST O R Y giving peo 1 closes ds derive do Advocate of the Get involved in JSM 2021! Section Wray Jackson e 30 rewar Conferenc ed talents to Statistical Government Statistics and Data Science professional Harry V. Roberts deadline deadline submission and housing open WSDS:accou Women of ntsin Statistics Year Award nomination Award Smith Scholarship and event request CSP 2022 early registration ntic and mean ingful visit using our shar n is to collect authe a story you would like toonshare, d. Samuel S. Wilks Memorial JSM 2021 meeting these events, nomination deadline submission deadline panel, and poster Our missio have For informati about most of , Kim the mo st goo iences. If you Waller awards nomination deadline WSDS 2021 concurrent, OCTO BER inator exper coord t.org erWSDS communications ASA: www.amsta in Interlaboratory Testing abstract submission deadline memb Pennsylvania 2021, Pittsburgh, ting and eetings Find out how on Page 32. W. J.Youden Award and tutorial proposal www.amstat.org/asa/m ASA’s markenomination course 7–9 ASA Meetings: nomination deadline CSP 2022 short submission opens email the deadline . t.org/ASA/Your-Career/A wards-and-Recognition Virtual Conference 15 Lester R. Curtin Award kim@ amst at.org ASA Awards: www.amsta 17–19 CSP 2021 8 SDSS 2021 regular registration opens , at GilliamLingzi Lu Memorial Award nomination deadline : www.amstat.org/asa/ed ucation Engineering Sciences abstract submission deadline nomination ASA Education 20 Statistics in Physical 14 JSM 2021 contributed Deming Lecture Award deadline202 SSNEY Award nomination deadline Educator deadline abstract submission SHARON HE and event request BIOP 2021 poster JSM 2021 meeting 22 submission opens BIOP 2021 invited abstract submission opens DECEMBER travel award—to 16 Student paper competition/ ULA Scholarship Gertrude M. Cox 15 e AIMER Dean DISCL 23 SASTRY PANT attend JSM—deadlin our application deadline its implications for of COVID-19 and ber of the ASA MAY and housing open monitoring the spread to deadlines and check The ASA is closely continue to adhere Being a mem 3 JSM 2021 registration and workshops. Please amstat.org. like more and tutorial proposal conferences , meetings, sent to meetings@ Questions may be CSP 2022 short course you ng My advice to 6 often for updates. makes me feel submission deadline event websites is to eng age a high- opens ICES VI regular registration than “just 7 statisticians oral abstract ASA early CSP 2022 concurrent r.” 13 th teache submission opens with the school ma deadline abstract submission 20 BIOP 2021 invited member news open registration and housing 27 WSDS 2021 early and oft en. ber MONTI Retired Mem ciate Dean KATHERINE Professor & Asso LIZ STUART most rewardi ng What’s been I was being about my invo lvement? I felt like ld stories! So into the wor So ma ny welcomed of statistics. little space! 41 Awards and Deadlines 43 People Y M News 44 Section Y S T O•RChapter • Committee News 45 Professional Opportunities Follow us on Twitter www.twitter.com/AmstatNews Join the ASA Community http://community.amstat.org Like us on Facebook www.facebook.com/AmstatNews Follow us on Instagram www.instagram.com/AmstatNews 2 amstat news december 2020
president's corner What a Year It Has Been! T he original plan for my last president’s col- we were able to have this conversation in the midst umn was to provide a recap of my presiden- of the virtual learning required by the pandemic. You tial year, assuming it would be business as can listen to the podcast at https://bit.ly/36NxI42. usual for an ASA president. Needless to say, this has not been a typical year for any of us. While there Number 7: Opportunity to Serve have been plenty of challenges, I am grateful for the on the ASA COVID-19 Task Force opportunity to be your president and end this year Although my colleagues on the ASA Board with renewed appreciation of our community. In deserve the credit for their substantive contribu- the spirit of “end of the year” lists, and in no par- tions, it was a privilege to serve with them. The ticular order, I want to share my top 10 with you. board supported the creation of the COVID-19 And you should know it was a challenge to keep the community and many of you shared your research list to 10 because there were so many highlights. and resources on the community, as well as during webinars and workshops. Number 10: Opportunity to Be the Keynote Speaker at CSP 2020 Number 6: Opportunity to Collaborate The Conference on Statistical Practice is one I really with Colleagues on the Presidential Wendy Martinez enjoy attending every year. I had the opportunity Initiatives to talk about data ethics, which is one of the criti- Not only have I learned a lot while working on cal topics for our community (IMHO). This was the initiatives, I now have a deeper respect for the also the topic of my May Amstat News column (see energy, talent, and spirit of my colleagues. I am https://bit.ly/3pC9GBR). looking forward to working with my LGBTQ+ and K–6 friends in the coming year, especially as Number 9: Opportunity to Connect we work together on 2021 President Rob Santos’ with the International Community initiatives to build community. of Statisticians, Biostatisticians, and Data Scientists Number 5: Opportunity to Although travel was restricted in 2020, I did have Learn About the Amazing Work the opportunity to spread my wings in the begin- Accomplished by the Committees ning of the year. I was honored to attend the 2nd That Make Up the Various Councils International Conference on Applied Statistics, Associations like ours depend on volunteers just which was held at the University of Dhaka Institute like you, and I thank all of you for serving. Most of Statistical Research and Training in Bangladesh, of the ASA committees are organized under four where I gave a keynote talk. This was followed by a councils: Awards, Education, Membership, and visit to City University of Hong Kong and Tokyo, Professional Issues and Visibility. Not only was I Japan. There, I met with the director-general of the able to appoint members to committees during my Institute of Statistical Mathematics, Hiroe Tsubaki, year as president-elect, but I participated in several and the president of the Japan Statistical Society, of their events in 2020. Two of my favorites were Shigeru Kawasaki. I will continue to make interna- the Meeting Within a Meeting for teachers and tional outreach an important part of my service to StatFest, where I participated in a panel on oppor- the community in the coming years. tunities in statistics and data science. Number 8: Opportunity to Interact Number 4: Opportunity to Work with Kids with the ASA Staff Contributing to education in statistics and data sci- My year as president has confirmed what I already ence is an essential responsibility of our profession. knew—our association is well served by the profes- Education has been a strategic goal of the ASA for a sional staff. All staff are appreciated, as they have long time, and our focus in 2020 was on statistical worked hard this year dealing with the many chal- and data science education in the early years (5–11 lenges we faced. However, I especially want to thank years of age). One of my fondest memories of this our executive director, Ron Wasserstein, who has year was the opportunity I had to chat with two been keeping the ASA ship on course. And I cannot middle-schoolers in a Stats + Stories podcast. It is a thank Donna LaLonde enough. She is not only a testament to our strong community relationships that colleague, but also a close friend. december 2020 amstat news 3
A Global JSM 2020 Thank you to the audience members around the world who provided their location during the talk! This map shows the locations of the 266 who responded to the request. See https://bit.ly/38Z1qps for the map and more. Number 3: Opportunity to Choose the profession! It was a challenge for our ASA meet- JSM Theme ings staff, presenters, exhibitors, and attendees to One of the first tasks I had as the 2020 ASA presi- change from an in-person conference to a virtual dent was to choose the JSM 2020 theme. JSM is one. Everyone stepped up and made it happen, one of the premier events for our profession, and however. It was particularly exciting to be able to the JSM theme is important because it can have an meet virtually with statisticians and data scientists impact on the content of the meetings. I had a lot of from around the world. The map included here fun coming up with a theme with the help of JSM shows the locations of viewers of my president’s Program Chair David Banks and the ASA Meetings talk. Although I was nervous, I enjoyed sharing Department staff. my thoughts with you! In case you missed it, you My very next JSM-related task was to select the can view the recorded plenary sessions at https:// President’s Invited Speaker. Erica Groshen gave a bit.ly/32SZaMC. wonderful talk highlighting the essential role of fed- eral statistics. This led to a World Statistics Day cele- Number 1: Opportunity to Serve bration that took place on October 20 (https://world- During a Challenging Time statisticsday.org). We had several wonderful panelists I have benefitted substantially from the ASA and discussants from around the world who con- community. I am grateful to have had opportu- tinued the conversation Erica started at JSM. The nities to give back in small ways. I know all of Harvard Data Science Review (https://bit.ly/3lJr9pM) you are also supporting our profession, our com- is planning a special publication with papers written munities, and our families … so thank you. I by the panelists. In case you missed it, you can view truly am looking forward to the next part of my the celebration at https://youtu.be/3rAZS3I3Vh8. ASA journey. It has been an honor to serve as the president of the ASA. Number 2: Opportunity to Come Together with My Colleagues at the Virtual JSM It is definitely a highlight of my year to learn more about the great work we are doing in our 4 amstat news december 2020
Nominate a Colleague for ASA Leadership Position ASA/AAAS Mass N ominations are being sought for ASA president-elect and vice presi- Media Fellowship dent candidates for the 2022 elec- tion. While the 2021 elections have yet to be held, the Committee on Nominations Applications Open needs time to evaluate recommendations to propose the best possible slate of candidates for these critical positions. As a member of the ASA, you recognize A pplications for the ASA/ the importance of leadership in our diverse, AAAS Mass Media Past ASA/AAAS Mass complex, and multidisciplinary field. You and Fellowship will be accept- Media Fellows all fellow ASA members deserve visionary ed until January 1, 2021. 2020: Jess Craig, NPR, leaders who can ensure our discipline has a Successful candidates will spend https://bit.ly/2UfuzV7 voice at the table when appropriate, whether 10 weeks next summer working it be in academe; research firms; federal, state, with journalists at a TV, radio, 2019: Diana Cai, STAT or local government; or nonprofit organiza- magazine, or newspaper outlet News, https://bit. tions. This is why we need your input. putting their statistics skills to use. ly/32CvPWS For this election cycle, the president-elect “One of will be selected from industry and the vice 2018: Irineo Cabreros, the most valu- MORE ONLINE president will be selected from government. able aspects of Read about Slate, https://bit. Think about your colleagues and associates the ASA ly/2UkW2oq this work was sponsorship of who are members of the ASA and would that, in writing this fellowship 2017: Nick Thieme, Slate, make good candidates for these positions. about statistics, at https://bit. https://bit.ly/2JUcGJj Think about members who have helped run I became intro- ly/3pmMPdx. a conference or are active in your section or spective about chapter. Then, nominate your choices for my own academic research,” scientific topics in clear and engag- the 2023 president-elect and vice president wrote Irineo Cabreros, a 2018 ing ways, better understand how by emailing elections@amstat.org. mass media fellow. “My experi- the media covers science, and build Supply as much information about your ence this summer hooked me. I a professional network of scientists nominee as possible to assist the committee left Slate flush with inspiration and journalists. In its 45-year his- in researching each candidate thoroughly for future projects and hungry to tory, the program has supported and discretely. keep going. I began the summer more than 700 fellows. The deadline for nominations is February as a dabbler in science communi- Learn more about being a 1, 2021. cation. Now, I don’t think I can AAAS Mass Media Fellow at imagine a future without journal- https://bit.ly/3eUaCMU. ism being part of it.” To apply, visit https://bit. Statistics Communication and Embedded in media outlets, ly/35mTWdM. Questions may Media Innovation Regina Nuzzo fellows learn how to communicate be sent to ASA Senior Advisor for at regina@amstat.org. n december 2020 amstat news 5
CHANCE HIGHLIGHTS Special Issue Illustrates Importance of Data Privacy Amanda Peterson-Plunkett, CHANCE Executive Editor I n 2006, Netflix hosted a data competition aimed at improv- ing their movie recommenda- tion system. The winners were awarded $1 million in 2009 for a model that offered more than 10 percent improvement over the com- pany’s own recommendation model. Netflix planned to host a follow-up competition but reversed the deci- Amanda sion in 2010 after a class-action law- Peterson-Plunkett suit (Doe v. Netflix) was filed against them alleging privacy law violations MORE ONLINE concerning the data set publicized Read the article by Arvind Narayanan for the original competition. and Vitaly Shmatikov Two years earlier in 2008, research- about Netflix’s ers at The University of Texas at privacy issues at Austin, Arvind Narayanan and Vitaly State University, associate editor of the Annals https://bit.ly/3pnkBiu. Shmatikov, showed that it was possible to identi- of Applied Statistics and Journal of Privacy and fy specific customers in the competition data set Confidentiality, and co-editor of CHANCE’s O (suggesting even political and religious affiliations Privacy, Where Art Thou? column. could be determined), even though Netflix had In columns, we turn to teaching and sports. performed a form of cursory anonymization. In the Teaching Statistics in the Health Sciences The Netflix example illustrates the importance column, Erin Blankenship and Ella Burnham of preserving confidentiality when sharing data share their online teaching experiences, a sets. In the most recent issue of CHANCE, a spe- topic many teachers can relate to during the cial issue, authors focus on statistical data privacy COVID-19 pandemic. In Taking a Chance in and confidentiality. The issue also features three the Classroom, Evangeline Reynolds explains guest editors: how to create engaging assignments using flip- Saki Kinney, senior research statistician at RTI books, demonstrating the method using the R International flipbookr package. Finally, in Beyond the Box Fang Liu, professor and director of graduate Score, Christopher Bilder discusses the flagstick studies in applied and computational mathemat- dilemma in golf: whether to leave the flag in or ics and statistics at the University of Notre Dame, out of the hole. senior editorial board member for BMC Medical As an ASA member, you can view the online Research Methodology, and co-editor of CHANCE’s version of CHANCE for free by logging into O Privacy, Where Art Thou? column your ASA account at www.amstat.org and looking Aleksandra Slavkovic, professor of statistics under My Publications. with appointments in the departments of statis- Would you like to write an article for tics and public health sciences and the Institute CHANCE? Submission instructions and writing for Computational and Data Sciences at Penn tips can be found at https://bit.ly/3plYBob. n 6 amstat news december 2020
Nominations Sought for Giving Day 2020 JABES Editor Raises Nearly $69,000 Amanda Malloy, ASA Director of Development T he International Biometric The ASA is a strong community of Society and American caring individuals. This was evident Statistical Association on October 2—ASA Giving Day— invite nominations for editor of when members posted messages of the Journal of Agricultural, hope and encouragement, signed Biological, and Environmental up to volunteer, and donated Statistics (JABES). nearly $69,000 in support JABES publishes articles of of ASA programs. immediate and practical value to applied researchers and sta- ASA Giving Day tistical consultants in the agri- Chapter Challenge cultural sciences, biological Winners sciences (including biotechnol- Region 1 – Washington ogy), and environmental scienc- Statistical Society es (including those dealing with natural resources). Region 2 – Chicago Chapter JABES is published quarterly Region 3 – San Francisco Bay ASA will continue to provide teachers by Springer in March, June, Area Chapter innovative resources to engage their September, and December. students, help the public better under- The editor reviews new submis- ASA Giving Day University stand the data that surrounds them, sions and sends selected papers Challenge Winner advocate for sound policymaking, and to associate editors, who also cultivate future leaders in statistics and review the papers and either Kansas State University data science. send a response to the editor Thanks to the generosity and volun- To learn more about what donations or the paper to referees for in- teer service of so many members, the can do, visit www.amstat.org/giving. depth reviews. Springer’s edito- rial tracking system is used for online submissions and the peer review process. Funds are pro- vided for editorial staff support organizing the JABES Showcase encouraged to apply and will be and office supplies. session at the IBC and JSM, and given equal consideration irre- The editor also works with reporting to the IBS Executive spective of race, gender identity Springer’s production editor to Board on impact factors and or expression, age, or nationality. create each issue and ensure time- other issues of importance. Nominations should be sent ly production and publication. The next editor will serve to JABES@biometricsociety.org JABES receives approximately a three-year term, from 2022 no later than January 15, 2021. 220 submissions a year. through 2025, with the transition Once received, nominations will Additional duties of the edi- beginning in 2021. be presented to the chair of the tor include writing a quarterly JABES is committed to build- JABES Management Committee report for the IBS Biometric ing diversity in leadership posi- for further consideration. Bulletin, overseeing the selec- tions in our discipline and, as Interested individuals are encour- tion of best papers in JABES, such, all qualified applicants are aged to nominate themselves. n december 2020 amstat news 7
An Interview with Margaret extrapolation needs to be a default strategy in pediatric drug development. Gamalo is also an active member of the European Forum for Good Clinical Practice – Children’s Medicine Working Party, working to establish decision criteria for the inclusion of ado- lescents in adult research. In the statistics profession, Gamalo is a member of the executive committee of the Biopharmaceutical Section and has served in multiple administrative and scientific capacities within the section since 2014. She enjoys writing and mentors a group of statisticians in research activities on topics related to Bayesian methods, evidence synthesis, causal esti- mation for RWD/RWE, and policy-oriented work on pediatric drug development. BIOP Report: Congratulations on your recent appointment as the editor-in-chief of the Journal of Biopharmaceutical Statistics (JBS). What is your vision on its mission, history, and current status? MG: The Journal of Biopharmaceutical Statistics (JBS) has been around for about three decades. It started back in the early 1990s and, since that time, you can Margaret Gamalo was recently appointed as the editor in chief of the Journal see how the industry has evolved over the years told of Biopharmaceutical Statistics (JBS). through the collective perspective of statisticians. It is fascinating to study the progression of scientific Yodit Seifu, Victoria Chang, and Junjing Lin, research published in the journal reflecting both the ASA Biopharmaceutical Section scientific and evolving landscape of drug develop- ment. For example, the first two decades exhibited M argaret (Meg) Gamalo is senior director statistical issues ranging from proper use of one-sid- – biostatistics, global product develop- ed vs. two-sided tests in hypothesis testing, appropri- ment – inflammation and immunology ate analysis for stability and expiry, bioequivalence, at Pfizer Innovative Health. She combines expertise noninferiority and superiority, subgroups and mul- in biostatistics, regulatory, and adult and pediatric ticenter trials, interim analysis and adaptive designs, drug development. Previously, she was a research multiplicity, linear models analysis of endpoints, adviser of global statistical sciences at Eli Lilly, meta-analysis, among others for which the journal where she helped secure the approval of baricitinib has provided the stage for consensus and application. as the first modern treatment for atopic dermatitis Since then, the journal has seen a transformation and position baricitinib as a first-in-indication in scientific topics influenced by shifts in research treatment for alopecia areata. Gamalo also helped and development and the growing number of stake- in the clinical trials for baricitinib as a treatment for holders. For example, a big trend has been the move COVID-19. to a more patient-centric health care model, closely Prior to working at Lilly, Gamalo was a math- followed by the impact that technology has on all ematical statistician for the Center for Drug areas of the life sciences and the changing business Evaluation and Research at the US Food and models. Most recently, many of the published manu- Drug Administration supporting regulatory scripts revolve on topics such as efficient trial designs, reviews of drugs in the infectious diseases and including the use of external data, estimation and ophthalmology therapeutic areas. She is an expert uncertainty for go-no-go decisions, finding optimal in pediatric extrapolation and leads the Pediatric individualized treatment rules or biomarker-guided Innovation Task Force at the Biotechnology treatments, treatment heterogeneity, and consider- Innovation Organization. On this task force, ations for regional and payer evaluation of multi- she heads a cross-functional think tank on why regional clinical trials, among others. Some proposed 8 amstat news december 2020
Gamalo, Editor of JBS solutions apply an agile, iterative test-and-learn worth the humble reasoning of a single individual,” approach, rather than running long and expensive we all know science is also strengthened through con- development processes to concoct the perfect solu- stant validation—the reproducibility of results, the tion. Other solutions often require modern tech- conduct of peer-reviewed, open literature research. nological innovation such as artificial intelligence Hence, the existence of other journals is also essential (AI) and machine learning (ML), which provide for quality scientific and statistical research. significant opportunities to enhance drug discovery, Furthermore, science and statistics moves and clinical development, and commercialization. grows with collaboration. There is more and more to When I wrote my editorial in December 2019 in know in the world, and one can only have so much time for the first issue under my editorship, I pon- in our heads. In fact, the share of stuff we know dered the role of scientific publishing in an evolv- as individuals is declining in any field. Inevitably, ing industry. I realized that while our problems and we need to collaborate as most research problems insights today are much different from when the require multiple kinds of expertise. journal was first envisioned, not much has changed in Collaboration in science and statistics is good for terms of its vision and mission. The journal remains making bold advances (i.e., innovation). Interaction committed to the principle that better education of with people with different perspectives or approach- statisticians enables informed debate and decision- es prevents us from getting tunnel vision. Hence, making about the valid application of new meth- one objective in scientific publishing should be to odologies and aids in addressing misuse of statistical collectively grow the biopharmaceutical statistics concepts (e.g., p-values) for scientific discoveries. field together through a feedback loop of continu- The journal will continue to strive to achieve ous scientific and statistical innovation. excellence by publishing articles that present impor- Of note, innovation is key because it is multi- tant new advances in an everchanging field of sta- plicative, meaning that the same input generates tistics within the pharmaceutical industry. JBS will greater output far beyond the biopharmaceutical MORE ONLINE always be a platform for education and dissemina- statistics field. The real problem, then, in scien- To read the entire tion of statistical research and innovation, a reposi- tific publication is sustaining statistical innovation, fall issue of the tory for statistical solutions and choices, and a forum which I believe is anchored on drivers of innovation Biopharm Report, visit https://bit. for scientific opinion on issues impacting methodol- (i.e., problems, constraints, and opportunities). ly/35p44my. ogy and applications in the pharmaceutical industry. While the biopharmaceutical industry may be a mature field with established and highly regulated BIOP Report: There are several statistical journals scientific and statistical problems, our problems can with a focus on statistics issues in drug develop- be unique given the interface of different stakehold- ment and many more with a broad focus on medi- ers (e.g., payor, regulator, patients, physicians, phar- cal statistics and biostatistics. In your mind, what maceutical companies). Capitalizing on this unique- are the competing journals for JBS? What is your ness to formulate innovative scientific and statistical view on the relationship between JBS and these solutions could have far-reaching implications on competing journals? What kind of journal would other fields. you like to see JBS become in the next few years? With this paradigm in mind, the journal will MG: There are two ways of thinking about the exis- strive to promote multidisciplinary collabora- tence of other journals (i.e., whether to look at them tive research as a logical response to the expanse as competitors or whether their existence comple- and pace of scientific revolution and transforma- ments the journal and enlarges the collective influ- tion of the field. Not one discipline will be able ence of statistics in the biopharmaceutical industry to integrate all aspects of any problem or issue of by broadening readership and impact of scientific interest alone with proper applicability and suf- publication). I prefer the latter, embracing the per- ficient viability or competitiveness across a multi- spective of abundance (i.e., there is an abundance of stake holder industry. Increased focus on statisti- scientific thought and research material for every- cal research that has good cross-functional appeal one). This, I think, is the better long-term strategy apart from just pure statistical interest is impor- for scientific publication and consistent with how tant. The journal believes that effective science is science has evolved throughout history. achieved not just by one discipline, but by the col- While Galileo Galilei may have stated, “In ques- laborative and multidisciplinary effort within the tions of science, the authority of a thousand is not entire biopharmaceutical field. december 2020 amstat news 9
Science and statistics will not meet Another initiative we are accessing currently is to harness the power of the crowd by highlighting key innovations or discussions in social media. I think its potential until the research culture as a leader in scientific publication, we need to be more proactive in disseminating information than enables and supports contributors from merely passive repositories of scientific thinking brought to use through a Google search. It is esti- all backgrounds and circumstances and mated that ~68% of Americans get their news from social media (see https://pewrsr.ch/3pitBpb). The ease of use of social media platforms for contributions of all kinds based on the communicating and disseminating information also makes them attractive to scientists. Furthermore, interests, skills, and resources available. I believe social media gives us the opportunity to engage directly with a wide range of audiences and helps us understand our readers. Within the next five years, we have several other initiatives planned, as well (e.g., partnering with a statistics professional organization on proceedings or BIOP Report: What are the new measures you are narrowing the proceedings on hot topics or break- taking to continue improving the quality and vis- throughs). There will be a few more changes along the ibility of the journal and make it truly impactful? way as we try to think about what the role of scientific MG: One of the initiatives I instituted when I publishing in a personalized information age means. assumed the role of editor-in-chief was to ensure How can we adapt to that environment and perhaps diversity in the editorial board. We have increased influence it as well, particularly in biopharmaceutical the number of women associate editors (AEs), and statistics? I am open to suggestions, and anyone is free currently there is a diverse pool of AEs representing to reach out with ideas on how we can improve. pharmaceutical companies, academia, and regula- tory agencies from various geographies. I realized BIOP Report: JBS has successfully published that a journal relies on multiple and varied voices several special issues in the past and attracted having a wide range of experiences. In fact, a diverse much attention. Do you plan to publish more and inclusive editorial board brings the different special issues in the coming years, and what are perspectives a journal needs to ensure quality and the topics of these special issues? unleash value-driving insights, methods, and prac- MG: We recently launched a call for papers for tices. Another consequence of a diverse pool of AEs special issues on real-world data/evidence (RWD/ is having a network to a broader pool of peer review- RWE) and in the implementation of estimands in ers who are much more engaged. clinical research. RWD/RWE is a growing area that We screen papers for appropriateness to be pub- still requires thought and consensus on how it can lished in the journal (i.e., papers that fit the aims be applied, given the range of possibilities. In the and goal of the journal). We identify novel meth- future, there will be a blurring of how evidence of ods and applications and aspire to ensure relevance effectiveness of investigational new drugs will be of topics while maintaining scientific integrity. We established. Moreover, this field will continue to also plan special issues to address questions or bring grow in the next decade, finding interconnections up more discussion about new and hot topics and with clinical trials, clinical practice through elec- weave manuscripts coherently through different tronic health records, and digital health. viewpoints or perspectives. Estimands, on the other hand, is a complex Finally, we rely on our reviewers to provide qual- issue that is quite difficult to explore upfront and ity scientific and statistical reviews. implement in the planning stage of a clinical trial. Diversity and inclusion must happen, even in However, currently, it is changing the way we scientific publishing. Science and statistics will not design trials, write the objectives, collect the data, meet its potential until the research culture enables conduct the trial, and perform analysis because and supports contributors from all backgrounds the framework requires us to be more unambigu- and circumstances and contributions of all kinds ous about the questions we would like to answer. based on the interests, skills, and resources avail- The complexity is also due to the presence of mul- able. Failure to achieve diversity and inclusion of tiple scientific questions of interest about relevant all stakeholders in science and statistics will slow treatment effects, interpretation of study results, progress in discovery and translation of knowledge and added value of drugs to different stakeholders to solving humanity’s most pressing problems. (i.e., regulatory, prescribers, patients, and payers). 10 amstat news december 2020
Our guest editors are busy connecting with key scientific leaders in this field, as well as disseminat- Biopharmaceutical Report Focuses on ing the effort through different social media ven- Statistical Issues in COVID-19 Trials ues. What we believe to be important is to have a balanced and informative issue that will serve as a The Biopharmaceutical Report editorial team invited definitive reference for these topics to many scien- authors from government, industry, and academia to tists and statisticians in our field. write articles about their perspectives on the impact For these special issues, the reviews will be of COVID-19 on clinical trials, particularly the statistical rolling (i.e., once the reviews are completed, the issues involved in designing new COVID-19 trials. The accepted manuscript will be posted on the webpage 2020 fall issue includes these articles. right away for access). Once a sufficient number of manuscripts is collected and reviewed, we will close Steve Wolf of Duke University, Peter Mesenbrink of the issue and publish it in print. I urge those who Novartis, Herbert Pang of Genentech, and Xiaofei are interested to reach out to Junjing Lin (Takeda), Wang of Duke University report a survey of COVID-19– Helen Qi (Bristol Myers Squibb), Yodit Seifu related clinical trials based on the data extracted from (Merck), or Bill Wang (Merck). Clinicaltrials.gov as of early October 2020. The article sets We will also launch another special issue on the stage for discussion about the status of and possible pediatrics very soon. Of note, the majority of the future design and statistical analysis issues in developing investigational drugs being studied in adults will a safe and effective vaccine and treatments for COVID-19. [be studied in] pediatric patients, as well—either through a requirement or in pursuit of an incen- Zachary McCaw of Google, Lu Tian of Stanford, and Lee- tive. The challenges of running trials in children are Jen Wei of Harvard summarize recent work about how to accelerating efforts in innovative trial design and quantify treatment effect and competing risk in COVID-19 analysis. We hope this special issue will provide a clinical trials. simple but comprehensive guide for statisticians/ clinical research scientists to determine the extent of Peter Mesenbrink of Novartis shares his experience development in a pediatric trial in accordance with designing several COVID-19 trials. the principles of extrapolation and how these tri- Mitchell Thomann, Michael Durante, and Paul Berg of Eli als can be streamlined to be as lean as possible to Lilly write about simulation studies they conducted to ensure they provide the maximum information with gain insight into choosing optimal study endpoints in a the minimum number of pediatric patients exposed to research risk. proof-of-concept trial. We are trying to have this special issue coincide Sheng Feng, Amanda Shield, and Andy Wilson of Parexel with a global virtual workshop on extrapolation in contribute a short article about the challenges and pediatric drug development. This workshop and possible solutions of conducting real-world evidence subsequent special is still in the planning stages, but studies on COVID-19 treatment. will focus on statisticians’ and clinicians’ experiences in pediatric drug development. An article by Yongming Qu and Ilya Lipkovich of Eli Lilly provides a comprehensive review of estimands and BIOP Report: As far as we know, many statistical estimation of treatment effect of clinical trials during journals are facing challenges in finding highly COVID-19 in the context of ICH E9. qualified reviewers to complete reviews in a short timeframe—say one and a half months. What In this issue, there is also an interview with do you think JBS can do to address issues such as Margaret Gamalo, the new editor for the Journal of delayed manuscript review? Biopharmaceutical Statistics, and a summary report from MG: Indeed, this is a big problem in scientific Statistical Methods in Oncology Scientific Working Group publishing. Our managing editor, Victoria Chang on type I error considerations in master protocols. (BeiGene), has been excellent in reminding AEs View the latest issue of the Biopharmaceutical Report at when the reviews are needed. We have been able to manage asking the reviewers to actively turn in their https://bit.ly/35p44my. reviews. Of course, there are some review slips here and there as this is all voluntary work. For special issues, we ask the guest editors to have their own have plans to expand our editorial board with folks system of ensuring expedient reviews by having a from the European Union and Asia. In fact, if you standby review committee. have an interest in serving as an AE and you have As I have mentioned earlier, having a diverse set the passion to provide service to biopharmaceutical of associate editors has been very helpful. We still statistics and the society, please reach out to us. december 2020 amstat news 11
We also encourage young scientists to take part Brilliant statisticians may sometimes be dis- in this endeavor actively. It does not require that one suaded by writing not because they do not know must be well experienced to serve as a reviewer. I how to write but by not trying. We are our own think the major criteria to be a good reviewer are limit. We need to believe that something different curiosity, critical thinking, and the ability to ask can happen in order to break old patterns, and we good questions. can choose that new outlook at any time. Part of I am aware that many of us will say we are eye- being an effective statistician is not only to develop balls deep with work. On the other hand, I argue or apply sophisticated numerical calculations, but that we need to take care of ourselves, as well. One also being an effective communicator in writing way of doing that is ensuring we retain our scientific and in speaking. and statistical thinking and keeping up to date on innovation and new statistical techniques. I always BIOP Report: As we know, you had extensive working am reminded that we may need to keep learning if experience in government and the pharmaceutical we want to be relevant and as we live longer. Perhaps industry. What is the impact of this unique experi- Mahatma Gandhi was right in saying that we need ence on your perspectives on the role of statistics to “learn as if you were to live forever.” and statisticians in clinical trials research? MG: I learned the principles of drug development BIOP Report: Do you have any advice for the statisti- at the FDA, and I learned how to apply them while cians who would like to submit manuscripts to JBS? understanding the challenges of drug development MG: My general advice to all statisticians, and not in industry. I realized many of the regulations in just to those who would like to submit manuscripts, clinical trials are common sense and centered on is be curious and tell a good story. Most breakthrough ensuring the safety of patients. Having reviewed discoveries started with curiosity—the impulse to seek hundreds of investigational new drugs (INDs) and new information and experiences and explore novel new drug applications (NDAs), what is the right possibilities. Curiosity is beneficial for all because it thing to do is sometimes very easy to spot because cultivates many levels, whether it is one’s organization it is rational. I can also see the difficulty with imple- or, more broadly, the society. In fact, curiosity helps menting mitigations from the industry side for society make better decisions. When we are curious, some of the concerns raised by regulatory agencies. we think deeply and rationally about decisions and I learned to assess what is ideal and what is appli- come up with more creative solutions. cable. In the case of the latter, there is no perfect Curiosity does not necessarily have to result in a solution most of the time, but the quality of the monumental breakthrough, and certainly publish- medicinal product and patient safety are para- ing in a scientific journal does not necessarily mean mount. Hence, when I think about my job respon- only novel solutions are entertained. Science moves sibilities and the role of a statistician in the biophar- by increments, not by leaps and bounds. Sometimes, maceutical industry, it may just be encapsulated by the insight to the problem is enough. the provisions of Title 21 of the Code of Federal What I also see as a problem is that there are Regulations, which is consistent with ensuring good times when statisticians hold back on their ideas, clinical practice. Of note, good clinical practice rec- fearing that they may be too obvious. I think great ognizes that protecting data integrity is part and ideas may sometimes seem obvious because the parcel of ensuring safety of patients. solution has all the parts of the question lining up More broadly, I think statisticians need to be and shedding light on a solution. Therefore, ‘obvi- involved as key decision-makers. When we can ous’ answers are not visible to most people, partly understand and interpret data correctly, our ability because most people are not thinking about the to identify crucial areas requiring attention in drug question. Ideas only come to those who recognize development are enhanced and our proposals for a problem and look for innovative solutions. I posit mitigating these key areas are likely to respond to that even Einstein could possibly not find a solution the needs of our organization or the industry. In an if he had the wrong question. age where data is essential for making big decisions, Inside every scientific discovery, there is a good whether in business or government, statisticians story. I think it is important to share that story, as I need to be at the table so we can assist and encour- am sure there are a lot of insights that went through age informed decision-making. (e.g., how the problem came about, why it is an However, this also entails that we need to important problem to pursue, how the solution was be able to communicate in the language that is discovered, why other solutions failed). These expe- understandable by nonstatisticians. Statisticians riences are actually very informative and could help may need to be comfortable communicating many researchers out there know or understand about the problem not just in terms of numbers. what works and what does not. We need to understand the whole problem and 12 amstat news december 2020
not just numerical ramifications (e.g., scientific, clinical, regulatory, payor, etc.) Having a holistic My general advice to all statisticians, view is what we need, so we can provide more valuable and insightful feedback. and not just to those who would like My experience on both sides of the industry (regulatory and pharma) has also shaped my col- laboration with many statisticians in the industry. I to submit manuscripts, is be curious have been more discerning on what topics are most impactful, and so I think statisticians need to influ- and tell a good story. ence scientific thinking and progress in the biophar- maceutical industry. Particularly, I learned how to think big, start small, and learn fast—our role in the industry is to have a broad vision while being mind- Consistent with the spirit of collaboration I ful of how we act on it. mentioned previously, I decided not to go with For more than five years, I have been using a another special issue on COVID-19 in JBS great deal of Bayesian methodology. However, I because it would then be in competition with realized that most sample sizes are driven by the the SBR effort. Instead, any COVID-19–related number of exposures needed to have sufficient data research identified as helpful to the scientific com- to establish safety. Hence the value of Bayesian munity or related research activities will be given methodology in terms of efficiency in late phases of priority and expedited review. This allows us to development may not be apparent to encourage a publish any research and findings with greater strong push for change. However, in areas of unmet speed and agility. need and in pediatrics, the use of Bayesian method- The main issue with developing drugs for ology is clear because of feasibility and because of COVID-19 is speed of innovation. However, many ethical principles of not having duplicative infor- of the tools for acceleration have been discussed mation to warrant translating conclusions from extensively in literature (e.g., adaptive design, data one population to another. That situation gave me sharing, etc.) What is lacking, from a statistical per- a better perspective to focus on what innovative spective, is on knowledge of appropriate endpoints advances can bring meaningful change in policy. in relation to patient population. Hence, COVID- In fact, most of these innovative methods have 19 disease progression models are needed to learn been expanded to applications of propensity scor- about how to conduct COVID-19 treatment clini- ing methods to augment clinical trials, particularly cal trials. Ensuring clinical trials have a common set in pediatrics, orphan diseases, and unmet medical of data that can help inform other development is need indications. So even in scientific research and also important. However, there is little data avail- policy, the words of Justice Ruth Bader-Ginsburg able to assess how this can impact speed of develop- reverberate: “Real change, enduring change, hap- ment. The best would be when data is already out pens one step at a time.” there, what can we learn from it so we can be better BIOP Report: The COVID-19 pandemic is having a prepared should there be another catastrophic event significant and long-lasting impact on how clini- of similar nature in the future? cal trials are conducted. Meanwhile, government, I do encourage statisticians to contribute to universities, and many pharmaceutical companies the scientific efforts for developing treatments for are working together to find vaccines and new COVID-19. I think it is a worthwhile endeavor treatments for this disease. Do you have a plan to and reminds us how interconnected we are. If we use the journal as a venue to promote the discus- do not collaborate, we will be in this situation for sion on challenging issues arising in clinical trial a long time. I believe this is the best time for science and designs and analyses? statistics. In fact, as I have mentioned previ- MG: Statistics in Biopharmaceutical Research ously, with uncertainty comes great innovation. (SBR) is already having a series of special issues on Problems and constraints are backdrops for oppor- the impact of COVID-19 on clinical trials and in tunity. As a cheery reminder, Sir Isaac Newton COVID-19–related research. Some of my friends produced an unbelievable number of exceptional and colleagues are already working hard on that results, including seminal experiments on the law area and I am amazed at the speed of coordina- of universal gravitation, while quarantined during tion and implementation. Two of the manuscripts the London plague of 1665–1666 (see https://bit. I have been involved in writing will be published ly/2IjhnMB), though I believe he must have been in that endeavor. curious and persistent even before that. n december 2020 amstat news 13
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