TITLE: Estimand in Real-world Setting and Targeted Learning in Generating and Evaluating Real-world Evidence
INSTRUCTOR: Jie Chen, Overland Pharmaceuticals and Susan Gruber, Putnam Data Sciences
MODERATOR: Weili He
Dr. Jie Chen is Chief Scientific Officer at Elixir Clinical Research and Senior Vice President and head of Biometrics at Overland Pharmaceuticals. Before joining Elixir and Overland, Jie was a distinguished Scientist in the Biostatistics and Research Decision Sciences at Merck Research Laboratories (US). He also worked as a senior global group head in several multi-national biopharmaceutical companies. Jie has over 27 years of experience in biopharmaceutical R&D and has been invited to give short courses at national or international statistical conferences. He is a co-chair for the phase III projects of the American Statistical Association (ASA) Real-World Evidence Scientific Working Group. Jie has co-authored a book on Medical Product Safety Evaluation: Biological Models and Statistical Methods (with Heyse and Lai) and published over 40 papers in peer-reviewed statistical journals. He is an elected Fellow of the ASA and a visiting member of the Center for Innovative Study Design, Stanford University.
Dr. Susan Gruber, PhD, MPH, MS, is the founder of Putnam Data Sciences, a statistical consulting and data analytics consulting firm. Her work focuses on the development and application of data-adaptive methodologies for improving the quality of evidence generated by observational and randomized health care studies. Prior to forming Putnam Data Sciences, Dr. Gruber was the Director of the Biostatistics Center in the Department of Population Medicine at Harvard Pilgrim Health Care and Harvard Medical School, and former Senior Director of the IMEDS Methods program at the Reagan Udall Foundation for the FDA.