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. 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.

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.

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 .