Abstract: Statisticians play a critical role in the pharmaceutical industry, contributing across all stages of drug development, from pre-clinical research to regulatory approval and post-marketing surveillance. This talk provides an overview of key statistical challenges in clinical trials, including randomization, recruitment prediction, effect estimation, multiplicity adjustments, and safety analytics. Additionally, career navigation insights will be provided, offering guidance for statisticians aiming to make impactful contributions in the pharmaceutical industry.

About the Speaker: Margaret (Meg) Gamalo, PhD is currently VP, Statistics Head for Inflammation, Immunology and Specialty Care in Pfizer Global Product Development. She combines expertise in biostatistics, regulatory science and adult and pediatric clinical development in multiple disease areas. Prior to joining Pfizer, she was Research Advisor, Global Statistical Sciences at Eli Lilly and Company and Mathematical Statistician at the Food and Drug Administration. Meg led the Pediatric Innovation Task Force at the Biotechnology Innovation Organization and a member of the European Forum for Good Clinical Practice – Children’s Medicine Working Party that provided guidance on inclusion of adolescents in adult research. She co-leads the scientific workgroups on Statistics in Pediatric Drug Development and the Statistical Perspective on AI/ML in Pharmaceutical Development within the Biopharmaceutical Section of the ASA. She is also the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Statistics in Biosciences. Meg is a Fellow of the American Statistical Association.