Dr. Margaret (Meg) Gamalo, PhD, Vice President and Statistics Head for Inflammation, Immunology & Specialty Care at Pfizer Global Product Development. She brings extensive expertise in biostatistics, regulatory science, and end-to-end clinical development across various disease areas in both adult and pediatric populations. Before joining Pfizer, she served as a Research Advisor in Global Statistical Sciences at Eli Lilly and Company and as a Mathematical Statistician at the Food and Drug Administration. As a Fellow of the American Statistical Association, she has led several industry initiatives, including scientific workgroups on Statistics in Pediatric Drug Development and the Statistical Perspective on AI/ML in Pharmaceutical Development within the Biopharmaceutical Section. She also chaired the Pediatric Innovation Task Force at the Biotechnology Innovation Organization and contributed to the European Forum for Good Clinical Practice– Children’s Medicine Working Party, which provided guidance on the inclusion of adolescents in adult research. She has held various positions in the Biopharmaceutical Section of the American Statistical Association and the Society for Clinical Trials. In addition to her leadership roles, Meg serves as the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Statistics in Biosciences. She has authored over 70 peer-reviewed scientific publications in areas such as Bayesian methods, evidence synthesis, win statistics, causal inference, and pediatrics among others.