Schwab, Barry H.
Affiliate Professor
Department: Biostatistics
Barry Schwab received his Ph.D. in Biostatistics from VCU in 1984. He currently serves as vice president and head of clinical statistics for the Neuroscience, Pain and Established Products programs at Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. He also has responsibility for the statistical support provided to the clinical programs from the J&J office in Shanghai. Schwab has been with J&J for 27 years, providing statistical expertise and strategic direction to many of the company’s investigational compounds, with contributions to product approvals in psychiatry, neurology, pain, dermatology, anti-infectives and hematology/oncology. His current job responsibilities include providing strategic input into development plans, trial designs, NDAs and WW regulatory submissions, product labeling and publications, participating in licensing and acquisition activities, and directing a staff of approximately 50 statisticians in the U.S., Belgium and China.
Schwab has been active in statistical professional society activities, serving on the PhRMA Biostatistics and Data Management Technical Group, as chair of the PhRMA/FDA Workshop on Risk Detection and as a program steering committee member and session chair for the ASA/Biopharm-FDA Workshop, the DIA Statistical Workshop and the BASS Statistical conference. For the past six years, Schwab has been the industry co-chair of the Annual FDA/DIA Statistics Forum, an open meeting to discuss regulatory and scientific issues associated with the development and review of therapeutic drugs and biologics. Schwab is an editorial advisory board member for Pharmaceutical Statistics, The Journal for Applied Statisticians in the Pharmaceutical Industry.