Biostatistics Expertise: Understanding Your Needs
Principal
Dr. Lavin is a well-known biostatistician with a long history supporting clinical trials to support product registrations and reimbursements as well as for public health advancement.
He co-founded Boston Biostatistics (BBI) in 1983 which became Averion International in 2001 and Aptiv Solutions in 2011 before being acquired by ICON plc in 2014. He served as CEO for 24 years. The CRO grew organically from 1 person to 175 people to become a full-service CRO.
He founded Lavin Consulting LLC (LC) in 2012 offering high end strategic advice to design, analyze, report, present, and defend drugs, devices, and biologics for regulatory and reimbursement approval. He currently is the Principal.
He has served as the Lead Biostatistician for 64 FDA approvals to date including 39 PMAs, 19 NDAs, 4 BLAs, and a de novo and HDE with more pending. These approvals have resulted in >$25B in increased client valuations.
He also advised FDA from 1983 through 2015 on product approvals and public policy matters as a Special Government Employee.
He authored or co-authored 180 peer-reviewed publications in the medical and statistical literature. These represent diverse therapies, disciplines, and methodologies. He was a member of the Harvard Medical faculty for >25 years.
Dr Lavin is recognized by his peers. He is the only person to be an elected Fellow of the American Statistical Association and the Regulatory Affairs Professional Society reflecting his many contributions to statistics, regulatory approvals, and medicine.