William F. McCarthy Ph.D. has 40 years of applied experience in mathematics, research methods, and statistics. He has an extensive background in pre-clinical studies, phase 1 through 4 studies, outcomes research, and epidemiology. Dr McCarthy has been the lead biostatistician or consulting biostatistician for 71 clinical trials, 14 observational cohorts, and 6 registries. He has worked in industry, academia, government and foundations. He has regulatory biostatistical experience with drugs, biologics and devices (in the US with FDA, in Europe with EMA, and in Australia with TGA).
Dr McCarthy retired as an U.S. Army Civilian in September 2018. As a Senior Medical Statistician, he served as the Chief of the Biostatistics Branch, Office of Regulated Activities, The US Army Medical Research and Materiel Command. He was a senior leader responsible for the regulatory oversight of contract research organizations (CROs) who provided full service statistical support for Office of the Surgeon General of the Army (OTSG)-sponsored non-clinical and clinical research. In addition, as an internal expert consultant, he was responsible for providing advice and recommendations regarding regulatory statistical issues: non-clinical and clinical product development plans; study and trial designs; statistical interpretation of safety and effectiveness data; and statistical talking points for regulatory meetings and communications with FDA and other health authorities. Dr McCarthy held Level 3 Certification as a Science and Technology Manager.
After retiring from the U.S. Department of the Army, Dr McCarthy has served as a statistical and regulatory consultant to pharmaceutical and biotechnology manufacturers regarding optimal data-driven approaches for supporting clinical evidence of safety and effectiveness of drug and biological products. In addition, he provides guidance on how to ensure the integrity, appropriateness and regulatory-compliance of study designs and statistical analyses used for new drug applications (NDAs) and biologics license applications (BLAs) for Department of Defense, Commercial and Academic Medicine clients.
Since 2010, Dr McCarthy has served as a Lecturer of Biostatistics for the Advanced Academic Programs (AAP) at the Johns Hopkins Krieger School of Arts and Sciences.