Philip T. Lavin, PhD, FASA, FRAPS

Scientific Advisor

Phil is a well-known biostatistician with a long history supporting clinical trials.  He was a member of the Biostatistics faculty at the Harvard School of Public Health and the Department of Surgery at Harvard Medical School where he was affiliated for over 25 years.  He co-founded Boston Biostatistics which became Aptiv Solutions before it was acquired by ICON plc. 

Phil has authored or co-authored over 180 peer-reviewed publications in the medical and statistical literature.  He innovated a new study design used widely for medical devices (quasi-non-inferiority design).  He has developed solutions for optimum timing of interim analysis, extending labeling for multiple endpoints, and devising composite endpoints and models for interim monitoring of adaptive studies.

He has served as the Lead Biostatistician for >60 original FDA approvals to date including PMA’s (37), NDA’s(19), BLA’s (4), 510k’s (4), CE Mark’s (4), a de novo, and an HDE with more pending.

Phil received his PhD in Applied Mathematics at Brown University.  He is a member of Who’s Who in the World as well as multiple professional societies.  He is the first and only person to be elected a Fellow of the American Statistical Association and the Regulatory Affairs Professional Society reflecting his many pioneering contributions to statistics, regulatory approvals, and medicine.  He has won multiple awards from professional societies.  He has served as an FDA SGE for over 30 years. He provides guidance in study design, data analysis, outcomes modeling, regulatory strategy, and international agency representation.  He has worked on renal disease studies for over 25 years.

Back to Home