Brenda Crowe is an Associate Vice President in Statistics at Eli Lilly and Company. She has more than 25 years of pharmaceutical industry experience. She obtained a PhD in Statistics from the University of Toronto. She has worked extensively with both clinical trials and observational studies. She has participated in or led several expert teams. As examples, she was a co-chair of the cross-industry Safety Planning, Evaluation and Reporting team, and served as the lead editor of the Council for International Organizations of Medical Sciences report on meta-analysis of safety data. She is a fellow of the American Statistical Association.

Yuan-Li is the Division Director of the Division of Biometrics IX, Office of Biostatistics, Office of Translational Science, CDER, FDA. The division is responsible for statistical reviews of regulatory submissions of hematology products including both benign and malignant products. She received a doctorate in Biostatistics from the University of North Carolina, Chapel Hill. She has over 25 years of combined experience in clinical trial setting across academia, pharmaceutical industry and FDA.

Mouna Akacha is the Group Head of the Statistical Methodology group of Novartis Pharma AG, based in Basel, Switzerland. She and her team provide internal advice for clinical projects in all development phases and therapeutic areas. She is engaged in developing and implementing innovative statistical methods for clinical projects covering estimand discussions and approaches for missing data, longitudinal data, and recurrent event data. Before joining Novartis, Akacha studied mathematics at the University of Oldenburg in Germany. She holds a PhD in statistics from the University of Warwick in the United Kingdom.

Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI by Medidata (a Dassault Systèmes Company) and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics in CDER at FDA. At Acorn AI Ruthie is part of a team creating analytical tools to improve the efficiency and rigor of clinical trials, an example of which is her Synthetic Control work. Ruthie holds a Ph.D. in Biostatistics from George Washington University.

Mallorie has been with FDA CDER’s Office of Biostatistics since 2016. She is a statistical team leader supporting the Office of Oncologic Diseases. She received her PhD in Biostatistics from the University of Arizona and BS in Statistics from UCLA. In addition to her review work, Mallorie’s research interests include estimands, statistical analysis of patient-reported outcomes in cancer trials, and missing data.

Renee Iacona is the Vice President of Oncology Biometrics at AstraZeneca where she is in her 23rd. year. Renee has led or been involved in various Cross Pharma Oncology statistical initiatives including issues related to Non-Proportional Hazards in Oncology drug development and sensitivity analysis methods related to Progression-Free Survival. Renee serves on Cytel Innovation Advisory Board, Vanderbilt University Graduate School Board and the University of Tennessee Foundation Board. She received her PhD and MPH from Vanderbilt University.

Dr. Rima Izem joined Novartis in February 2021 where she supports statistical methodology development and use in all phases of therapeutic development. In her prior roles in academia and the US Food and Drug Administration, she designed or reviewed clinical studies across a wide range of therapeutic areas and data sources (clinical trials and observational data; efficacy and safety). She also developed new methods for causal inference and signal detection in claims databases and electronic healthcare data. Her current methodological interests include causal inference, hybrid designs (clinical trials data and real world data), and statistical methods in small samples (e.g., rare diseases or pediatrics).

Lisa Lupinacci holds a B.S. in Mathematcis from Villanova Univeristy and M.S. and Ph.D. degrees in Statistics from Virginia Tech. She is currently the Senior Vice President of Biostatistics and Research Decision Sciences at Merck. In this role, she has oversight for end to end statistical, epidemiology and health economics support for all of Merck's product development. During her 25 year career, Lisa has worked on multiple products in the vaccine, oncology and infectious disease areas. She has spent 21 years as a statistician and 4 years as a drug development team leader for several large infectious disease programs, an opportunity which gave her a much broader knowledge of drug development and much deeper insights into leadership.

Dr. Fairouz Makhlouf is the deputy director for Division VIII in the Office of Biostatistics, Office of translational science, Center for Drug Evaluation and Research, FDA. Since joining FDA in 2006, Fairouz focuses in providing support for research and regulatory evaluation of generic drug product. Fairouz received her Ph.D in Mathematical Statistics from American University, Washington D.C. in 2005.

Erik Pulkstenis joined AbbVie in 2018 as the Vice President and Head of Data and Statistical Sciences in support of clinical development strategy, data science, statistical analysis and reporting/analytics. Erik has more than 20 years of experience in drug and device development and clinical research. He has demonstrated success building, rehabilitating and leading biometrics departments including organizational design and operating model definition/implementation. He is also passionate about organizational leadership and culture.

Venkat is Head of Biometrics and Data Sciences at BMS. Prior to BMS, Venkat was a partner at ZS, a mngt consulting firm, where he led R&D clinical services. Prior to ZS, Venkat held leadership roles at BMS, Novartis Onc. and GSK. Venkat joined BMS in 2012 leading the early dev. biometrics and in 2016, took responsibility for the specialty pipeline, leading early and late stage biometrics. Prior to BMS, Venkat led the biometrics at Novartis Onc, and was involved with several dev. programs including Tasigna and Affinitor. Venkat has a PhD in Statistics from Temple Univ. and an MBA from Wharton Business School. Venkat is a member of Statistical and Data Science community and has served on the board of Biopharm. Section of American Stat Assoc.

Dr. Maro is an Assistant Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is also the Operations Lead for the Sentinel Operations Center (housed at Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute) as part of the U.S. Food and Drug Administration’s Sentinel System. The Sentinel Operations Center is responsible for the coordination of data curation, management, and utilization activities among multiple data partner sites covering data on several hundred million patients.

A team leader and a senior statistical reviewer at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in statistics from Statistics Program of Department of Mathematics at University of Maryland at College Park in 2015 and her Ph.D. in Chemical Engineering from Department of Chemical Engineering at Iowa State University in 1999. She received four FDA Outstanding Service Awards for significant efforts and contributions in statistics related to reviews and research in Chemistry and Manufacturing Control and biosimilar evaluation. She has published more than 35 papers in the statistical, medical, and engineering journals.

Ram C. Tiwari received his MS and PhD degrees from Florida State University in Mathematical Statistics; he is a Fellow of the American Statistical Association, and a past President of the International Indian Statistical Association. He has published 200+ research papers on a wide range of statistical topics.

Dr. Stella Grosser has over 25 years of experience in statistical consulting, biostatistics, and biomedical research. Since 2015, she has been division director of the division of biometrics VIII in FDA/CDER, which conducts statistical reviews of abbreviated new drug applications as well as carrying out related research as part of CDER's generic drug program. She has worked as a reviewer and team leader across multiple therapeutic areas in CDER. Prior to joining FDA, she was an adjunct assistant professor of biostatistics at UCLA.

Rebecca Hager is a statistical reviewer in the Division of Biometrics III supporting the review of COVID-19 products and the Division of Hepatology and Nutrition (DHN) in the Center for Drug Evaluation and Research (CDER) at the FDA. Rebecca joined the FDA in 2016 after receiving her Ph.D. in Statistics from North Carolina State University.

Lisa is a member of the Statistical Methodology group at Novartis and is based in Basel. Prior to joining the pharmaceutical industry, Lisa was a Lecturer in Statistics at Lancaster University, and held a UK Medical Research Council Career Development Award in Biostatistics. Her research interests are in clinical trials, including group sequential tests, adaptive designs for treatment selection, and Bayesian approaches for early phase dose-escalation trials. More widely, she is interested in developing approaches for leveraging existing information in trials, extrapolation, and methods to evaluate the probability of success of a drug development program. Lisa holds a PhD in Statistics from the University of Bath.

Dr. Rothmann (Mark) is the Director of the Division of Biometrics II. He earned his Ph. D. in Statistics at the University of Iowa in 1990. He then spent the next nine years as a professor at various universities before coming to the FDA in 1999. At the FDA, when he was a reviewer and team leader he was involved in the review on Oncology, Hematology, and Metabolism and Endocrinology products. He has done research in several areas involving the design and analysis of clinical trials and co-authored the book Design and Analysis of Non-Inferiority Trials. He leads three Office of Biostatistics Working Groups and Committees in Bayesian Analysis, Drug Trials Snapshots and Pediatric Studies and has serves on many other groups.

Robert Beckman, M.D. is an oncology clinical researcher and biomathematician focused on improving the way cancer therapies are developed and utilized. He has co-invented novel clinical strategies for proof of concept studies, basket trials, and biomarker driven clinical development, as well as novel therapeutic strategies incorporating tumor evolution. In a previous 18 year industry career, he played leadership roles in forming 4 oncology clinical research groups. He has contributed approximately 300 published articles, book chapters, and presentations, emphasizing quantitative approaches to basic and applied oncology, including a recent book on master protocols. He currently leads the DahShu Innovative Design Scientific Working Group.

Nareen Katta works as the Head of Data Science and Analytics at AbbVie. Nareen has over 20 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the advanced analytics strategy, that covers both Scientific and Business Operations across Clinical Development Continuum, Geostrategy and Study start-up, Centralized and Risk Based Monitoring, Site Engagement, Business Performance, Precision Medicine, Patient Safety and R&D. In addition, Nareen is actively engaged in evaluating the opportunities created by technology trends like big data, automation, machine learning and AI, digital health etc. and strategically instantiating them at AbbVie to drive organizational transformation

Antara is the Director of Statistics at AcornAI by Medidata. Antara is part of a team responsible for implementation of external controls in clinical drug development. Prior to this, Antara worked for Bristol-Myers Squibb for over a decade. Antara has deep and broad experience in pharmaceutical research and development; from discovery all the way through to clinical trials. Antara received her PhD in Biostatistics from University at Buffalo.

Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas and is the lead scientific secretariat of the Methodology Working Party. He also is the lead of the Statistics subgroup of ICH E11A on paediatric extrapolation, sits on ICH E6 R3 Annex 2 group, and is the Regulatory Chair of both groups. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA.

Lihua Yue works as an Associate Director in the Global Biometrics and Data Sciences group at Bristol-Myers Squibb. She received her PhD in Statistics from Western University, Canada. She has worked with both clinical trials and observational studies in different therapeutic areas. Her current focus is on RWE projects, where external real-world cohort was created as a comparator for patients from clinical trial to evaluate comparative effectiveness of treatment of interest versus conventional therapies in the real-world settings.

Dr. Yong Ma joined the FDA as a mathematical statistician in 2015 and she became a Team Lead in 2020. She obtained her doctorate degree in Biostatistics from the George Washington University. Before Joining the FDA, she worked as an assistant research professor at George Washington University and her work was mostly on diabetes prevention studies which lead to numerous publications. After joining the FDA, she has been focusing on methodology tailored for post-marketing safety study such as causal inference and meta-analysis. In addition to her regulatory review work, she is also actively engaged in contemporary methodology research such as machine learning and natural language processing.

Heinz Schmidli works as an Executive Director in the Statistical Methodology group at Novartis, Basel, Switzerland. Since he joined the group in 2007, he contributes to the development of innovative approaches for the design and analysis of clinical trials, with a focus on Bayesian methods. In 2012 he received the Paul-Martini-Prize of the GMDS (jointly with Tim Friede), and in 2020 the Novartis distinguished scientist award.

Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency processes, interacting with external stakeholders, and coordinating demonstration projects as well as guidance development. Dr. Concato joined FDA from Yale School of Medicine and the U.S. Department of Veterans Affairs, where he was a clinician, educator, independent investigator, research center director, and Professor of Medicine. He has a BE degree from The Cooper Union, MD & MS degrees from New York University, and an MPH degree from Yale University.

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016. He is a Fellow of the American College of Physicians and in 2022 he was elected to the National Academy of Medicine.

Brent is director of oncology, a Biostatistics lead of the renal cell carcinoma and prostate cancer indications and has worked in drug development at BMS for the past 16 years following 2 years of academic work as an assistant professor. He earned his PhD in Biostatistics from the University of Pittsburgh in 2003. His interests include time to event statistical methods, clinical trial designs and analyses and oncology research. His recent work has included the development of immuno-oncology agents Yervoy and Opdivo for multiple indications. Brent has completed multiple ironman triathlons, rode his bike across the US, run many marathons and ultra-marathons as he and his wife raise their 8 children.

Martin Posch is professor for medical statistics at the Medical University of Vienna. From 2011-2012 he worked as statistical expert at the European Medicines Agency (London, UK) in the Human Medicines Development and Evaluation sector, where he contributed to guideline development and the assessment of study designs. His main research interests are group sequential trials, adaptive designs and multiple testing, focusing on applications in clinical trials. Martin Posch serves as Associate Editor of Biometrics and Biometrical Journal and is Observer at the EMA Biostatistics Working Party. Furthermore, he is member of the EU Patient-centric clinical trial platform IMI EU-PEARL.

Paul Schuette joined the FDA in 2008 and has served as the Scientific Computing Coordinator for the Office of Biostatistics in CDER since 2010. Paul serves on the FDA’s Scientific Computing Board, Modelling and Simulation Working Group and multiple other working groups and boards. Paul is the Principle Investigator (PI) for a Cooperative Research and Development Agreement for data anomaly detection and participates in other FDA efforts to assure data integrity and data quality. Paul received his bachelor’s degree in mathematics from Kansas State University and earned his masters and Ph.D. degrees from the University of Wisconsin-Madison, with a specialization in probability theory.

Richard C. Zink is Vice President of Data Management, Biostatistics, and Statistical Programming at Lexitas Pharma Services, Inc. He was the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, and is currently host of the Biopharmaceutical Section Statistics Podcast and Associate Editor for the DIA journal Therapeutic Innovation & Regulatory Science. Richard is author, editor, and contributor to 8 books on statistical topics in clinical trials and clinical research. He holds a Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill, where he serves as Adjunct Professor of Biostatistics. Richard was named a Fellow of the American Statistical Association in 2020.

RDML Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration. In this role she provides leadership, oversight, and direction on minority health, health disparity, and health equity matters for the Agency.

Dr. Aloka Chakravarty is currently the Sr. Statistical Advisor in the Office of the Commissioner, FDA for real-world data and evidence activities related to collaborations on COVID-19 and others. She is also working on select strategic data initiatives at FDA with the Chief Data Officer.Prior to that, she was the Deputy Director of the Office of Biostatistics in CDER, FDA. She is an internationally recognized thought leader in multi-regional clinical trials, safety evaluation, real world data and evidence, surrogate markers and biomarkers in drug development. Dr. Chakravarty served as an Adjunct Faculty in Department of Statistics, FAES, NIH and has been on Advisory Board of multiple academic institutions.

Shanti Gomatam is a senior Mathematical Statistician in FDA/CDER. She currently works for the division that assesses quantitative safety. She has over 29 years of experience in academic and regulatory environments, of which almost 20 years have been with the FDA. Her experience at the FDA covers both CDER and CDRH, efficacy, safety, therapeutics and diagnostics. She received her Ph.D. from Florida State University. Her statistical interests span a range of topics, she has been focusing on the estimand framework recently.

Yihua has dedicated 23 years of career in Abbott/Abbvie. Her experience spans across immunology, neurology, infectious diseases, and analgesia. Her combined statistical knowledge, scientific insights, the ability to look beyond statistics and the operation excellence have made her a key contributor to the successes of many development programs filling the gaps of unmet medical needs. She has co-authored manuscripts in The New England Journal of Medicine (NEJM), The Lancet, Annals of Internal Medicine, Journal of Dermatology, Journal of American Academy of Dermatology, Journal of the European Academy of Dermatology and Venereology, and British Journal of Dermatology. She is a core member of TransCelerate SAP working group.

Dr. Weili He is a Senior Director, head of Global Medical Affairs Statistics at AbbVie Inc. Prior to AbbVie, she worked at Merck & Co., Inc. for over 20 years. Weili has published extensively in the areas of adaptive designs (AD), benefit-risk assessment (BRA), and RWE methodology research. Since joining AbbVie in February 2017, Weili has involved extensively in RWD and RWE research for evidence generations. She is the co-founder and co-chair of the ASA Biopharm Section (BIOP) RWE SWG since 2018. The SWG’s efforts in the past 2+ yeas resulted in three peer-review publications in a statistical journal. Weili is also the BIOP Chair 2021, an AE for the journal of the SBR since January 2014, and an elected Fellow of the ASA.

Ian received his PhD in modeling spatial epidemic populations at the University of Strathclyde in the UK in 1998. He then worked as a statistician at Pfizer and also worked for about 2 years as a Statistical Assessor at the UK regulators (the MHRA). Ian joined AstraZeneca in 2009. He is currently the Respiratory/Infection Biologics and Vaccine Products Strategy Lead, Late-stage Development within the Respiratory & Immunology Therapeutic Area based in the Cambridge in the UK where he is responsible for ensuring statistical, programming and information science input and support is given to late stage development programs including for the COVID area.

Gregory Levin is the Associate Director for Statistical Science and Policy in the Office of Biostatistics in the FDA’s Center for Drug Evaluation and Research. He received a Ph.D. in biostatistics from the University of Washington in 2012. Greg has experience supporting drug review across a wide range of therapeutic areas and has represented CDER on several policy and guidance working groups, including efforts related to adaptive design, master protocols, benefit-risk, and the evaluation of effectiveness.

Dr. Zhong is the Vice President of Biometrics at REGENXBIO. Prior to REGENXBIO, he was a Group Head at Biogen, accountable for Innovative Analytics, Rare Disease Statistics, and others. He has 20 years of industry experience successfully bringing the needed treatments to patients and advancing statistical innovation for drug development. Currently, he is the Rapporteur of the ICH E20 Expert Working Group, leading the development the ICH E20 guideline on Adaptive Clinical Trials. He was an invited expert panelist for the FDA public meeting on Promoting the Use of Complex Innovative Designs in Clinical Trials. He has coauthored book chapters, over 50 manuscripts in peer reviewed medical and statistical journals, and over 100 presentations.

Björn Bornkamp works in the Statistical Methodology Group at Novartis in Basel, where he provides consulting to statisticians and clinical teams on topics related to dose-finding, subgroup analyses, Bayesian statistics as well as estimands and causal inference.

Joan Buenconsejo is VP, Head of Cardiovascular, Neuroscience, and Early Development Biostatistics at Bristol Myers Squibb (BMS). Prior to BMS, she was a strategy lead at AstraZeneca and a statistics team leader at CDER, FDA. She is a long-time DIA member, has chaired the DIA Statistics and Data Science Community, has worked with the Advisory Council of North America, and served as program chair and steering committee member for the Annual FDA/DIA Statistics Forum, and track co-chair for the DIA Annual Meeting. Dr. Buenconsejo received a master’s degree in mathematical statistics from University of California, Irvine, and a MPH and PhD in biostatistics from Yale University.

Dr. Martin Klein is a Mathematical Statistician in the Division of Biometrics VIII, Office of Biostatistics, CDER, FDA, where he focuses on providing support for research and regulatory evaluation of generic drug products. Dr. Klein’s research areas include statistical analysis in the presence of missing data, statistical analysis using pharmacokinetic models, adaptive design in bioequivalence studies, statistical ranking of populations, and statistical computing. Dr. Klein received his Ph.D. in Statistics from the University of Maryland, Baltimore County in 2009.

Tsai-Lien Lin is Chief of the Vaccine Evaluation Branch, Division of Biostatistics in the Center for Biologics Evaluation and Research, FDA. Her previous experience includes pharmaceutical industry and Center for Drug Evaluation and Research in both clinical and nonclinical areas. Since 2006, her work has been focused on statistical applications in vaccine development. She holds a Ph.D. in Biometry from the University of Texas, Health Science Center, School of Public Health in Houston.

Former FDA Expert Statistical Consultant. Research applications include clinical trials, genomics, surveys, malaria prevention; environmental, health and public policy. Methods research emphases include Bayesian modeling, the analysis of observational studies, research synthesis and surveys. Honors and awards include President and also Honorary Life Member of the International Biometric Society; elected member of the International Statistical Institute; Fellow of the American Statistical Association, of the American Association for the Advancement of Science, of the Institute of Mathematical Statistics; an honorary degree from Hasselt University, Belgium.

Pallavi Mishra-Kalyani, Ph.D. is the Deputy Director of the Division of Biometrics V, Office of Biostatistics in the Center for Drug Evaluation and Research (CDER). Since joining the Food and Drug Administration (FDA) in 2015, Dr. Mishra-Kalyani has contributed to the efforts to address the statistical issues related to the potential use of Real World Data and Real World Evidence for regulatory purposes. Her research interests include statistical methods for observational data, causal inference, and non-randomized trial design. Dr. Mishra-Kalyani received her Ph.D. in Biostatistics from Emory University and her Master’s degree in Epidemiology from the T.H. Chan School of Public Health at Harvard University.

Elena is a Scientific Director in the Statistical Modeling & Methodology group of Johnson & Johnson Innovative Medicine. Her work has a focus on estimands, missing data methodology and their implementation in clinical trials. Elena is the lead of the J&J Estimands and Missing Data Working Group and the co-chair of the Estimand and Missing Data Working Group of the International Society for CNS Clinical Trials and Methodology. Elena joined Johnson & Johnson in 2004 and before that she worked at Pfizer for several years. She has been involved across the years in several therapeutic areas including Immunology, Cardiovascular and Metabolic, Pain and CNS.

John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and a past Editor of the journal Pharmaceutical Statistics.

Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has supported the methodological development in various areas of drug development, including dose finding, estimands, multiple testing, and adaptive designs. He was a member of the ICH E9(R1) Expert Working Group on 'Estimands and sensitivity analysis in clinical trials' and currently serves on the ICH E20 Expert Working Group on 'Adaptive clinical trials'.

Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials. Dr Bill Wang was elected as a Fellow of American Statistical Association (2018) and received the DIA Global Inspire Award in 2017 .

Dr. Collins, Director of the Office of Biostatistics at FDA/CDER, leads a staff of statisticians responsible for statistical review of regulatory submissions promoting innovative, science-based, quantitative decision-making throughout the drug development life cycle. Prior to FDA, she led global operations in statistics, data management and statistical programming in the pharmaceutical industry. She led global teams in pioneering electronic data capture in several large companies and established unified worldwide strategies for efficient and faster drug development. She received her BS in Mathematics from the American University of Beirut, her PhD in Statistics from Boston University and completed a MS in Computer Science from NYU.

Dr. Craig Mallinckrodt holds the rank of Distinguished Biostatistician at Biogen in Cambridge MA. He has extensive experience in all phases of clinical research. His methodology research focuses on longitudinal data, missing data, and estimands, along with placebo response and related design issues. He is Fellow of the American Statistical Association, has led several industry working groups on missing and longitudinal data, and received the Royal Statistical Society’s award for outstanding contribution to the pharmaceutical industry.

Dr. Snapinn has had a long career as a biostatistician in the pharmaceutical industry. After receiving his PhD from the University of North Carolina, Dr. Snapinn worked at Merck and Amgen, where he led the biostatistics and statistical programming functions. In 2019 Dr. Snapinn formed Seattle-Quilcene Biostatistics LLC to do biostatistical consulting. Dr. Snapinn is former editor of Statistics in Biopharmaceutical Research and is a fellow of the American Statistical Association.

Yanping Wang is the global head of the Immunology Statistics team at Eli Lilly and Company. He got his PhD in Statistics from Virginia Tech in 2002. His research area of interest includes clinical trial design and analysis, and quantitative decision making.

Dr. Binbing Yu is an Director of Statistical Science in the Oncology Statistical Innovation group in AstraZeneca. He serves as the statistical expert across the whole spectrum of drug R&D process, including early-clinical and clinical research, design, operation and manufacturing, clinical pharmacology, oncology medical affairs and post-marketing surveillance. He obtained his PhD in Statistics from the George Washington University. His primary research interests are clinical trial design and analysis, cancer epidemiology, cause inference in observation studies, PK/PD modeling and Bayesian analysis. He has over 80 publications in scientific and statistical journals and published three books on cure modeling, immunogenicity and RWD/RWE.

Dong Xi works as an Associate Director in the Statistical Methodology group at Novartis Pharmaceuticals. He provides consulting services to clinical teams and develops innovative statistical methodologies in multiple comparisons, adaptive design, dose finding, estimands and causal inference.

Dr. Bruce Binkowitz is Vice President of Biometrics at Shionogi Inc. where he leads the Biostatistics, Data Management, and Statistical Programming departments. Bruce has more than 30 years experience in the Pharmaceutical Industry at Merck and Co. and then Shionogi, Inc. as a Statistician, working across many therapeutic areas and across all phases of drug development. He has presented at all the major Statistics conferences and has publications spanning more than 30 years, including his contributions as a thought leader on the topic of multiregional clinical trials. Dr. Binkowitz is a Fellow of the American Statistical Association(ASA), and was the 2020 Chair and is current Past-Chair of the Biopharmaceutical Section of the ASA.

Lei Nie has worked for FDA since 2007 and previously worked for Georgetown University where he served as the director of Graduate Study in the Department of Biostatistics, Bioinformatics, and Biomathematics. He graduated from the University of Illinois at Chicago with a Ph.D. in statistics in 2002. He is an elected ASA Fellow and has authored/authored a total of 99 peer reviewed publications.

Barbara Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative effort to improve standards for the planning, conduct, and regulatory environment of international clinical trials. She is the Director of the Regulatory Foundations, Ethics, and the Law at the Harvard Catalyst (https://catalyst.harvard.edu) and Director of Regulatory Policy for SMART IRB (www.SMARTIRB.org). She currently serves on the BODs of Management Sciences for Health, Edward P. Evans Foundation, and Vivli.

Dr. Pandu Kulkarni is Chief Analytics Officer – R&D / Vice President – Statistics, Data & Analytics. His organization is comprised of statisticians, statistical analysts, data analysts, and others working in the full pharmaceutical research cycle, from discovery to commercialization. Pandu is on one of the Board of Directors for CDISC and Accumulus. He also is the chair of the Biopharmaceutical Statistical Leaders Consortium. He is a fellow of the American Statistical Association. Pandu joined Eli Lilly and Company in 2000, has held numerous leadership positions including technical and management positions within and outside of Statistics. He obtained his Ph.D. in Statistics at the LaTrobe University, Melbourne, Australia.

Dr. Man is currently Global Clinical Development Head for Communicable Disease at Novartis Pharma AG and qualified in biochemistry and medicine in the UK after which he specialized internal medicine and medical oncology. He has over 32 years of experience in pharmaceutical drug development both in large pharmaceutical and biotech companies, having participated in over 30 successful new drug applications across multiple disease areas and therapeutic drug classes. He currently responsible for clinical drug development programs in Malaria, Leishmaniasis, COVID-19, Dengue Fever, Chagas disease and other Neglected Tropical Diseases.

Sara Hughes is SVP & Head, Biostatistics at GSK. Her global group provides statistics, programming and data science resources for the full range of R&D activities in GSK's pharmaceutical and vaccines portfolio. Sara herself sits on GSK's Clinical Development Leadership Team and also the senior R&D technical and investment governance boards, where she and other Biostats leaders champion the use of quantitative decision-making approaches. Externally, Sara is a past-president of PSI, and was a member of the PSI Board of Directors for nine years. Sara has published around 30 papers in peer-reviewed journals.

Amy Xia is Vice President, Center for Design and Analysis at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies over the past two decades. Currently, she heads up the Center for Design and Analysis organization which includes Biostatistics, Design & Innovation and Data Sciences at Amgen, providing leadership and holistic vision for strategic drug development and driving innovative approaches across Amgen’s portfolios for evidence generation and decision-making. Amy received her PhD in Biostatistics from the University of Minnesota, and her medical degree from Peking University, China.