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 .

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.

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.

More than 20 years' experience in Biotech, CRO & Pharma. Built and managed biostatistics, statistical programming & data management groups. Clinical trial experience in Oncology, Inflammatory Diseases, Dermatology & HIV. Keen interest in functional alignment, statistics in decision-making & quantitative Benefit-Risk methodology.

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).

Dr. Lin joined the Division of Biostatistics at Center for Biologics Evaluation and Research (CBER), US FDA in 2011 as a Mathematical Statistician with special focus on Adaptive Designs. In her current role, Dr. Lin performs critical statistical reviews of regulatory pre-marketing submissions to the Office of Tissues and Advanced Therapies (OTAT) and provides statistical trainings to non-statisticians within CBER. She supervises the FDA interns in conducting biostatistical methodology researches in the area of adaptive designs that are related to CBER regulated biologics products and medical devices.

Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section and on the Regional Committee of the Eastern North American Region of IBS. She is a Fellow of the ASA and the President-Elect of the ASA. With an MS in Biostatistics from UNC, and PhD from Emory, her research interests focus on clinical trial designs. She has co-authored papers in Statistics in Medicine, Clinical Trials, and Statistics in Biopharmaceutical Research.

Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Research Fellow at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis of clinical trials. In 2011, Karen helped form and led the DIA Bayesian Scientific Working Group and currently serves as past-chair. This group includes members in Industry, Regulatory, and Academia. Her research interests include Bayesian design and analysis of clinical trials and master protocols. In 2016, Karen was elected a Fellow of the American Statistical Association.

Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry and Government. His career includes senior positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer. He has held faculty appointments at six different universities, served as Chairman of CDISC, and is past president of the Society for Clinical Trials. Frank holds a BA in Statistics and an ScM and PhD in Biostatistics. Frank is a Fellow of the American Statistical Association, The Royal Statistical Society, and the Society for Clinical Trials and is widely published across a wide variety of research topics.

After her training at McGill University and at the University of Waterloo, she began her career as a statistician supporting agricultural research before moving to Philadelphia to join SmithKline Beecham in 1991, which went on to become GlaxoSmithKline. She joined AstraZeneca in November 2011 and is currently VP and Head of Biometrics and Information Sciences in Global Medicine Development. She has supported early & late-stage clinical development and marketed products-primarily in the area of Cardiovascular and Metabolism - and has led global teams of experts across many disciplines. Névine has been a statistical Reviewer for The Lancet and is the (co-) author of 25+ publications in peer reviewed biostatistics and medical journals.

Dr. Kun Jin is a Statistical Team Leader at the Center for Drug Evaluation and Research, U.S. Food and Drug Administration. His team supports the Division of Neurology Drug Products and conducts statistical reviews and research on regulatory submissions of neurological drug products. Dr. Jin received his B.S. in Applied Mathematics from Anhui University, China, M.S. in Statistics from Beijing University, China, and Ph.D. in Statistics from the University of California, Berkeley. Prior to joining the FDA, he was a faculty member at the University of Pittsburgh School of Medicine.

Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining the FDA in 1999. He received a BA in Chemistry from the University of California, Davis and an MS and DrPH in Biostatistics from the University of California, Los Angeles.

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.

Mark Levenson is currently the Director of the Division of Biometrics VII in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA). At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug safety problems. He contributes to statistical policy and guidance development in the areas of drug safety, real-world data, and regulatory evidence. He is a member of the CDER Medical Policy Program Review Committee and the FDA Real-World Evidence Committee. Dr. Levenson received a Ph.D. in Statistics from the University of Chicago and a B.A. from Cornell University in Mathematics.

Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing responsibilities, including Statistical Reviewer, Team Leader, and Acting Deputy Division Director. She had extensive experience in multiple therapeutic areas for both new and generic drugs. In addition, she was a research faculty member at Johns Hopkins University and a statistical consultant at the University of Kentucky. Dr. Luan is President-elect of Chinese Biopharmaceutical Association and Board Member/Committee Co-chair of FDA Alumni Association.

Cristiana Mayer is the Head of Biostatistics at Johnson & Johnson Vision, a company dedicated to the eye care, eye health and eye products. She has 20+ years of experience in the pharmaceutical industry. After 18 years in drug development at Janssen R&D LLC working in different therapeutic areas and 5 years in Statistical Modeling & Methodology group, Cristiana is currently leading the biostatistics and data management groups across the Surgical and Vision Care businesses of JNJ Vision. Her current interests are in CID, Bayesian designs and patients’ engagement. Her recent publications are about simulation practices for innovative designs, ethics and innovation in the pandemic and patient engagement in rare diseases.

Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team Lead and later as Deputy Division Director. In these roles, Mat is involved in the quantitative assessment of safety covering a spectrum of statistical issues ranging from retrospective assessment of safety signals to prospective design of safety outcome trials.

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.

Dr. Haoda Fu is an Associate Vice President and Enterprise Lead for Machine Learning and AI at Eli Lilly and Company. An ASA and IMS Fellow, he's also an adjunct professor at the University of North Carolina Chapel Hill and Indiana University School of Medicine. With a Ph.D. from the University of Wisconsin - Madison, Dr. Fu joined Lilly in 2007 and has since published over 100 research papers spanning Bayesian adaptive design to AI, appearing in journals like JASA, JRSS, and JAMA. Active in the data science community, he's taught AI topics at FDA workshops, served on boards like ICSA and ENAR, and is an associate editor for JASA theory and method since 2023.

Hana Lee, PhD, is a Senior Statistical Reviewer of the Office of Biostatistics in the CDER, FDA. She leads and oversees various FDA-funded projects intended to support development of the agency’s RWE program including multiple Sentinel projects to develop causal inference framework for conducting non-randomized studies, to enhance analytic capacity using machine learning-based methods, and to implement sensitivity analysis for RWE studies at the study design stage, and the BAA project on Targeted Learning. She is currently a co-lead of RWE scientific working group of the American Statistical Association (ASA) Biopharmaceutical Section.

Joo-Yeon Lee is a senior mathematical statistician in Division of Biometrics VII at FDA/CDER. Since she joined FDA in 2007, she developed an expertise on pharmacometrics and design and analysis of post-market drug safety studies. She has reviewed sponsor led studies as well as collaborated with other investigators in FDA-led studies in Sentinel Distributed System and federal data partners. She has played a leading role in causal inference method working group in Division of Biometrics VII. Prior to joining FDA, she earned Ph.D in Biostatistics from Brown University.

Dr. Thomas’ primary interest is causal inference methods, particularly using large data sets such as registries, Medicare claims and electronic health records. She is a co-investigator on the NIH-supported Statistical Methods for Complex Data in Cardiovascular Disease and primary investigator on the AHRQ-supported Matching Methods for Comparative Effectiveness Studies of Longitudinal Treatments. She uses causal inference methods in collaborations in cardiovascular disease (CHAMP-HF, ORBIT-AF registries; ACTION-NCDR and CRUSADE registries linked to Medicare; ARISTOTLE and NAVIGATOR clinical trials) and uterine fibroids (COMPARE-UF). She teaches the causal inference course in the Biostatistics and Bioinformatics Masters and PhD programs.

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

Jacqueline Corrigan-Curay, JD, MD, serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality medications including serving on executive governance committees and overseeing policy development on real world evidence, prescription drug promotion, clinical trial oversight and innovative trial design.

Kevin J. Anstrom, PhD, is an Associate Professor of Biostatistics and Bioinformatics at Duke University. He is the Associate Director of Biostatistics at the Duke Clinical Research Institute.

Lisa LaVange, PhD, is Professor and Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill and former director of the department’s Collaborative Studies Coordinating Center (CSCC). From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and was the 2018 ASA President.

Dr. Mullen is the Global Clinical Leader for Neuroscience at AstraZeneca. He is responsible for medical leadership of lanabesestat and for emerging neuroscience products. He previously held positions in late-phase neuroscience clinical development and was the medical leader on numerous regulatory submissions. Dr. Mullen graduated from Tufts University and received his medical degree at the University of Pennsylvania, and was on the faculty at the University of Pittsburgh.

José Pinheiro has a Ph.D. in Statistics from the University of Wisconsin – Madison, having worked at Bell Labs and Novartis Pharmaceuticals, before his current position as Global Head of Statistical Modeling & Methodology in the Statistics and Decision Sciences department at Janssen Research & Development. He has been involved in methodological development in various areas of statistics and drug development, including dose-finding, adaptive designs, and mixed-effects models. He is a Fellow of the American Statistical Association, a past-editor of Statistics in Biopharmaceutical Research, and past-president of ENAR

Mr. Schuirmann was born in Takoma Park, Maryland and raised in Washington, D.C. He received his B.S. in Zoology from the University of Maryland in 1971 and his M.S. in Biometry from Cornell University in 1975. Mr. Schuirmann began working at the Center (actually, we were “The Bureau of Drugs” in those days) in March 1977. His chief areas of responsibility in his years at FDA have been the design and analysis of bioavailability/bioequivalence studies. Today, he is a senior statistical expert in bioavailability/bioequivalence in Division of Biometrics VIII, Office of Biostatistics, OTS, Center for Drug Evaluation and Research, FDA.

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.

Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests are in Bayesian Analysis, Design of Innovative Trials, Platform Trials, Clinical Trial Simulation, and Hierarchical Modeling.

Hrishikesh Chakraborty has statistical expertise in single and multi-site pragmatic randomized and cluster randomized clinical studies, disease modeling, predictive modeling, big data methods, and risk analysis. His statistical research includes cluster randomized trial, probabilistic modeling, longitudinal and time-to-event methods, simulation studies, and other advance statistical methods. He has served in key data coordinating center roles as PI, co-PI, and co-I for large multicenter clinical and cluster randomized pragmatic trials. He has published widely on a variety of topics in statistical and scientific journals, led workshops in different topics, and presented his research as a keynote, invited, and contributing speaker.

Dr. Hong Liu-Seifert, Ph.D., is a senior research advisor for the Alzheimer’s Disease Global Development Team at Eli Lilly and Company. She earned her doctorate degree in statistics from Tulane University in 2001 and upon graduation joined Lilly. She has worked on multiple major neuroscience compounds contributing to the regulatory and commercialization success of these assets. Currently she is the group leader of the statistical function supporting clinical research efforts for investigational treatments for Alzheimer’s disease, and has made significant contributions to the AD field.

Josephine Park has more than 18 years experience in patient-reported outcomes (PRO) and health economics and outcomes research in industry, and also in the hospital. Currently at GlaxoSmithKline, she is leading PRO efforts across a range of therapeutic areas and phases of product development. Prior to joining GSK, she was responsible for PRO strategies and implementation to support value propositions for Alcon/ Novartis ophthalmic medical device and surgical products and for ophthalmology products. With broad experience in PRO development and alignment across FDA and EMA, she has developed and supported PRO endpoints for medical products across a range of therapeutic areas.

Tom Permutt is Associate Director for Statistical Science and Policy, Office of Biostatistics, Center for Drug Evaluation and Research at FDA. Tom’s contributions to causal inference in clinical trials date from 1989 when he proposed an instrumental-variable estimator of the effect among the treated. Tom was FDA liaison to the National Academy of Sciences panel on missing data and is FDA topic leader on the ICH E9 expert working group.

Sherri Rose is an Associate Professor of Health Care Policy (Biostatistics) at Harvard Medical School, where her work is centered on developing and integrating innovative statistical approaches to advance human health. Dr. Rose coauthored the first book on machine learning for causal inference and co-leads the Health Policy Data Science Lab, where she directs projects in computational health economics and clinical informatics. Her honors include an NIH Director’s New Innovator Award to develop robust estimators for generalizability. Dr. Rose received her Ph.D. in Biostatistics from UC Berkeley before completing an NSF Mathematical Sciences Postdoctoral Research Fellowship at Johns Hopkins University

Doug Faries graduated from Oklahoma State University and joined Eli Lilly and Company in 1990. Doug’s experience at Lilly includes research on novel clinical trial designs, supporting development, registration, and commercialization of Neuroscience compounds, and research on statistical methodology for observational data. Currently, Doug is a Research Fellow in Global Statistical Science, leading real world data research and analytics across the Lilly portfolio. He has authored or co-authored over 100 peer-reviewed manuscripts.

Dr. Francis is the Director of the Data mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, CDER, FDA.In that capacity he directs a trans-disciplinary group of senior sciences to test, create and operate data analysis program facilitating the efficient use of scientific methods to evaluate complex data information in order to make regulatory decisions for drug approval and drug safety.

Eric Genevois-Marlin holds a degree of statistician from Institute of Statistics from University of Paris (ISUP). Over the past 23 years, he worked as a Clinical Statistician at Rhone-Poulenc-Rorer which became Aventis, and joined Sanofi 10 years ago. He worked on multiple therapeutic domains, including anti-infective, oncology, cardiology/thrombosis, neurology from phase I to phase IV. He is now Vice-President of Biostatistics and Programming at Sanofi Research and Development.

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.

Toshimitsu Hamasaki is the Director of Data Science at National Cerebral and Cardiovascular Center, Japan. His research interests include the design, monitoring, analyses, and reporting of clinical trials. He was the member of ICH-E5 Guideline Implementation Working Group as a representative of Japan Pharmaceutical Manufacturers Association to develop the Q & A document on the guideline. He is a steering committee member of CONSORT Adaptive Design Extension Project. He is the elected member of International Statistical Institute and the fellow of the American Statistical Association.

Dr. Hobbs completed a doctoral degree in biostatistics at the University of Minnesota and then joined The University of Texas MD Anderson. He was promoted to Associate in 2017, and then recruited to Cleveland Clinic to found a Section of Cancer Biostatistics. He joined The University of Texas in August 2020 as a tenured Associate Professor. In 2016, Dr. Hobbs was selected by The University of Minnesota for the Emerging Leader Award. Recognized as an expert in clinical oncology research methodology, in 2017 Dr. Hobbs was invited to lead the publication of National Cancer Institute’s Clinical Trials Design Task Force with the goal of providing national, consensus recommendations for first-in-human cancer drug trials that use seamless designs.

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. Zineh is Director of the Office of Clinical Pharmacology (OCP) at the U.S. FDA. He has held various leadership positions at FDA including Associate Director for Genomics in OCP (2008-2012), Co-Director of the CDER Biomarker Qualification Program (2009-2015), voting member of the CDER Medical Policy Council (2016-present), and others. Dr. Zineh also leads CDER’s Model-informed Drug Development (MIDD) program. Dr. Zineh leads a staff of 246 regulatory, research, policy, communications, program/project management, and administrative staff in FDA’s efforts to enhance drug development, optimize pharmacotherapy, and promote innovation through clinical pharmacology and experimental medicine principles.

Stuart leads the Analytics & Data Sciences team at Biogen supporting Research & Development of pioneering medicines for neuroscience patients. He holds a Doctorate in Mathematics from Sussex University, U.K. and is an expert in adaptive model-based dose-finding and Bayesian methods applied to proof of concept and patient subgroups. Stuart's more recent research areas focus on the application of machine learning approaches to multisource data (e.g., clinical outcomes, biomarkers, imaging, RWD) to define better measures of patient disease burden, more accurately predict disease course, and improve contextualization of drug activity. His goal is to enable patients and care-givers with learnings from data to impact their lives for the better

Jessica M. Franklin joined Optum in 2020 after 10 years as faculty in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, where she remains affiliated as a Visiting Scientist. Dr. Franklin has extensive experience in designing and leading studies of the effectiveness, safety, and utilization of medications from large healthcare databases, including health insurance claims and electronic health records. She led the development and application of a wide range of novel methods in pharmacoepidemiology and co-founded the FDA and NIH-funded RCT DUPLICATE project focused on producing an empirical evidence base for the validity of real-world evidence on medications.

Rob received his MD, PhD with honors from the University of Maryland, with a research focus in Neuropharmacology. He then completed his residency in Neurology at UCLA. After completing his chief resident year, he joined Abbott within clinical development. Rob joined Amgen in 2012 as the Global Development Lead for the Neuroscience programs and then became the Therapeutic Area Head and Vice President of Neuroscience Development. He is currently the head of a quantitative science organization comprising global biostatistics, study design and data sciences called CfDA. He has authored or co-authored more than 25 peer-reviewed scientific publications.

Dr. Devan Mehrotra is Associate Vice President, Clinical Biostatistics, at Merck Research Laboratories. He has made significant contributions towards the research, development and licensure of numerous medical drugs and vaccines. He is an Adjunct Associate Professor of Biostatistics at the University of Pennsylvania, an Associate Editor for The American Statistician and Pharmaceutical Statistics, and a Fellow of the American Statistical Association. He has served as a subject matter expert for the Bill and Melinda Gates Foundation, the US National Academy of Sciences, and the International Council on Harmonization (ICH). His current focus is on statistical approaches for enabling personalized medicine.

John R. Peters, MD graduated from the George Washington University School of Medicine. He is a Family Physician certified in Forensic Medicine with a Certification in Public Health from Georgetown University. He practiced Family and Emergency medicine in MN, later joining the US Army FP residency teaching staff at DeWitt Army Hospital Ft Belvoir and Uniformed Services University of Health Science. In 1992 he moved to the FP residency program of Georgetown University. He has been Director of Managed Care and Associate Director of an MCO. In 2006 he joined the FDA 2009 where he is currently the Deputy Director of the Office of Generic Drugs.

Tim Rolfe has over 20 years of experience working as a statistician at in the pharmaceutical industry. He is currently Director of Risk Based Monitoring at GlaxoSmithKline R&D. He has been part of GSKs RBM team since 2013, providing statistical leadership in the development and implementation of GSK’s RBM strategy within clinical trials. Before joining GSK, Tim studied Applied Statistics at Sheffield Hallam University and holds a MSc in Medical Statistics from the University of Leicester in the UK.

Tony Guo, PhD, is Executive Director, Head of Biometrics China, for the Chinese biotech company BeiGene. Before joining BeiGene, Dr. Guo served as Senior Director, Head of AP Statistics Group, for Merck Research Laboratories. He also worked for Sanofi China as Manager of the Statistics Group and Lead Statistician. Dr. Guo holds adjunct teaching positions in Beijing Normal University, and is Chair of DIA China Statistics Community, a member of the China Clinical Trial Statistics Working Group, and Secretary General of the Beijing Biometrics Association. Dr. Guo earned his PhD in Statistics from North Carolina State University. His research focuses on statistical inference, benefit-risk assessment, missing data analysis, and adaptive design.

Jennifer Schumi is a Director of Statistical Standards in AstraZeneca’s Biometrics and Information Sciences, Advanced Analytics Centre. She develops and maintains cross-therapeutic area standards and guidance documents on statistical methodology. Prior to joining AZ, she spent ten years at Statistics Collaborative, Inc., providing guidance on statistical issues to pharmaceutical and biotechnology clients. She has a special interest in using data visualization tools to simplify monitoring, both internally for risk-based quality monitoring and externally to support independent data monitoring committees. She holds an MS in Statistics (Iowa State University) and a PhD in Biostatistics (Harvard University).

Dr. Wilson has worked as a mathematical statistician at FDA for more than 33 years.  He is currently a Senior Staff Fellow with the Office of Biostatistics at the Center for Drug Evaluation and Research (CDER).  Steve received his doctorate in Biostatistics from the University of North Carolina, Chapel Hill, in 1984. His professional experience has also included positions with the East West Center, the Indonesian Central Bureau of Statistics, the University of North Carolina, the Federated States of Micronesia and the World Bank. His professional interests and activities are currently focused on issues related to the improvements in clinical trials science and practice, data standards, and the review of drug and biological therapies.

Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.

Fellow of the American Statistical Association since 1988. Areas of research interest include use of Bayesian methods to improve effectiveness of the drug development process, adaptive trial design (including group sequential methods), evaluation of safety data from clinical trials, application of data mining and Bayesian methods to pharmacovigilance, use of data mining to identify relationships that can be used to design future trials, meta-analysis, modeling and simulation techniques to reduce cost and unnecessary patient exposure in drug development, and application of decision science methods to drug development strategy.