Dr. Lavin is a well-known biostatistician with a long history supporting clinical trials. Dr. Lavin was a member of the Biostatistics faculty at the Harvard School of Public Health and a member of the Department of Surgery at Harvard Medical School where he was affiliated for over 25 years. He co-founded Boston Biostatistics in 1983 now known as Aptiv Solutions.
Dr. Lavin has authored or co-authored 160 peer-reviewed publications in the medical and statistical literature. He has innovated analytic techniques for evaluating the contributions of baseline and serial biomarkers. Dr. Lavin has continuously worked on biomarkers since his initial support for PSA (Hybritech) and CA-125 (Centocor) over 30 years ago. Most recently, he served as the Lead Biostatistician for the Exact Science sDNA test for colorectal cancer screening. He has been the Lead Biostatistician for 50 FDA approvals to date including 38 PMAs (inclusive of PSA and CA-125), more to date than any other biostatistician. He has presented multiple studies to regulatory agencies in defense of design and approval.
Dr. Lavin received his PhD in Applied Mathematics from Brown University in Providence, Rhode Island in 1972. He is a member of Who’s Who in the World as well as multiple professional societies. He is the only person to be elected a Fellow of the American Statistical Association and the Regulatory Affairs Professional Society reflecting his many contributions to statistics, regulatory approvals, and medicine. He also has served as a Special Government Employee for 30 years where he has advised FDA on complex statistical and policy issues. He has won multiple awards from professional societies. He remains hands on and available for study design, complex statistical matters, and regulatory strategy consulting inclusive of agency representation, reimbursement modeling, biostatistics, clinical trials design, medical devices, and adaptive designs.