Gerry Gray Email & Phone Number

• Biostatistical consulting with expertise in clinical trial design and analysis, statistical computing, FDA strategies.• Extensive FDA review and management experience: 3 yrs reviewer, 3 yrs Cardiovascular & Ophthalmic Statistics Branch Chief, 12 yrs Division of Biostatistics Management.• Ph.D. in statistics, B.S. in biology, with >20 years’ experience in clinical trial design and analysis, 5 years’ experience in survey sampling.• Extensive experience with review of clinical and laboratory study design and analysis for regulatory approval of medical devices.• Lead and manage diverse groups of statisticians, lab scientists, and computational scientists. • Lead editor of FDA guidance documents on diagnostic devices, Bayesian clinical trials, adaptive clinical trials.• 12 yrs guiding statistical component of CDRH presentations to FDA Public Advisory Panel meetings, 5 yrs scientific computing leadership at FDA.

Listed skills include Data Analysis, Clinical Trials, Biostatistics, Statistics, and 2 others.