2025 UCSF-Stanford CERSI Bayesian Thinking in Clinical Research Course Instructor Biographies

Stephen J Ruberg, PhD. – President, Analytix Thinking (Retired Distinguished Research Fellow, Advanced Analytics, Eli Lilly and Company)

Steve has been in the pharmaceutical industry for over 40 years with experience in all phases of drug development, particularly clinical drug development. He has published many articles on statistical methodology for drug development, including Bayesian statistics. He is also an invited speaker at statistics and medical conferences internationally.

Natalia (Natasha) Muehlemann, MD, MBA - VP, Clinical Development & Innovative Statistical Consulting, Cytel

Natalia has over 20 years of experience in the Life Sciences industry and combines medical, statistics, data science, and strategic expertise, enhancing value through evidence generation, advanced analytics, and stakeholder engagement. In her position of VP at Cytel, Natalia focuses on the integration of adaptive and innovative designs into clinical development strategies. Natalia also acts as an Expert Jury member for the European Commission’s European Innovation Council and SMEs Executive Agency and other investor forums.

Jan Priel, PhD - Senior Research Consultant, Cytel

Jan Priel is currently a Senior Research Consultant at Cytel. He has experience as a sponsor statistician, CRO statistician as well as a DMC statistician on a variety of Phase I-III studies. Jan’s specialties include Bayesian adaptive trial design and Bayesian statistical modeling for prediction and (causal) treatment effect estimation. Jan has a Doctoral degree in Mathematics from the University of Hamburg (Germany).

Kyle Wathen, PhD - VP, Scientific Strategy & Innovation, Cytel

Kyle’s accomplishments include more than 40 scientific publications, numerous awards, and the development of several software packages for designing and simulating novel adaptive Bayesian designs, as well as websites for conducting clinical trials employing new statistical methodology. Prior to joining Cytel, Kyle was Director of Statistical Modeling and Methodology at Janssen before becoming Head of Advanced Analytics at Gilead. Prior to Janssen, Kyle was at M.D. Anderson Cancer Institute, where he had been for over eleven years and was a major contributor on many Bayesian adaptive trials, including ISPY2.

Satrajit Roychoudhury, PhD - Executive Director/Head of Statistical Research & Innovation, Pfizer Inc.

Satrajit has 17 years of extensive experience in working with different phases of clinical trials for drugs and vaccines.  His research interest includes survival analysis, the use of model-based approaches, and Bayesian methods in clinical trials. He has published many articles in peer-reviewed journals and was invited to speak at statistics and medical conferences internationally.

Zhong Gao, PhD – Statistical Reviewer, FDA

Zhong is a statistical reviewer at the Center for Biologics Evaluation and Research (CBER), reviewing statistical design and analysis of clinical studies of all phases. At CBER, he has reviewed numerous regulatory submissions, including BLAs and INDs in the areas of allergens, biotherapeutics, cell and gene therapy, blood, and vaccine-related products.

Scott Berry, PhD — Senior Statistical Scientist, Berry Consultants

Since 2000, Scott has been involved in the design of hundreds of Bayesian adaptive clinical trials of pharmaceuticals and medical devices and has become an opinion leader in the field of Bayesian adaptive clinical trials.

Ross Bray, PhD - Senior Advisor, Statistical Innovation Center, Diabetes, Eli Lilly and Company

Ross has spent the last 10 years in the pharmaceutical industry with experience in all phases of drug development and focusing on diabetes and cardiovascular disease. Most recently Ross has specialized in consulting with study teams on the design of phase 2 and 3 clinical trials.

Margaret (Meg) Gamalo, PhD - VP, Statistics Head for Inflammation and Immunology, Pfizer R&D

Meg 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. 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. Meg is a Fellow of the American Statistical Association.

Robert “Skip” Nelson MD PhD - Executive Director, Pediatric Drug Development, Child Health Innovation Leadership Department (CHILD), J&J Innovative Medicine

Dr. Nelson was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration. Prior to joining the FDA, Dr. Nelson spent 20 years in the academic practice of pediatric critical care medicine, most recently as Professor of Anesthesiology, Critical Care, and Pediatrics at The Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania School of Medicine. Dr. Nelson is a member of the International Council for Harmonisation (ICH) E11A Working Group developing a guideline on the use of extrapolation in pediatric drug development plans. 

Yun Wang, PhD. - Deputy Division Director for Division of Biometrics II in the Office of Biostatistics (OB) at Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Yun supervises the statistical reviews of applications for cardiology and nephrology, diabetes, lipid disorder, obesity, general endocrinology, bone disease, and pediatric and maternal health product development. Before taking her current role, Dr. Wang was a statistical team leader and reviewer at FDA, a senior principal biostatistician at Novartis Oncology, and an assistant professor at the University of Pittsburgh. Her research interests include Bayesian design and analysis, missing data handling, etc.

Pritibha Singh, DSc (in progress), MS – Analytics and Insights, Corporate Affairs, Novartis AG

Pritibha has extensive experience in technology, pharmaceuticals, and banking across diverse geographies, as well as a blend of expertise in drug development (psychology, statistics, and business). With 17 years of drug development experience, she is now working on sustainable strategies for decentralized clinical trials at Novartis while completing a Doctorate at ETH Zurich.

Melvin Munsaka, PhD - Senior Director and Head of Safety Statistics, Statistical Sciences, AbbVie Inc.

Melvin has been in the pharmaceutical industry for more than 25 years. He co-leads some initiatives of the ASA Biopharm Safety Scientific Working Group, the Bayesian Scientific Working Group, and PHUSE Safety Analytics and Data Visualization and Open-Source Technology Sub-teams. He is also a lecturer at the University of Chicago.

Mani Y Lakshminarayanan, PhD - Global Product Statistician, Early Oncology Biometrics, AstraZeneca; Fellow, American Statistical Association

Mani has over 35 years of experience working in the pharmaceutical industry. Mani has held several positions, both in management as well as in research. He has worked in several therapeutic areas, including oncology, neuroscience, bone, respiratory, immunology, and endocrinology. Mani has published extensively in peer-reviewed journals, technical reports, and book chapters and has co-authored a book on the Bayesian Applications in Pharmaceutical Development in 2018. He is a founding member of the DIA Bayesian Working Group. Mani has taught as a part-time lecturer at the Department of Statistics and Biostatistics/Rutgers University for several years.