University of North Carolina, Chapel Hill, NC
Dave McSorley, MPH, is a Director of Biostatistics at RTI-HS. He has over 35 years of professional experience working with public health and clinical trial data. During this time, he worked as a clinical statistician in the gastrointestinal, neurology, and immuno-inflammation therapy areas designing clinical trials, writing protocols and statistical analysis plans, performing statistical analyses, and supervising permanent staff and contractors. Additionally, he has formulated and implemented analysis plans for observational studies and patient registries using propensity score methods, and has extensive experience in the analysis of randomized studies using categorical data methods, nonparametric statistics, multiple comparisons procedures, and generalized linear mixed models. Mr. McSorley has led the statistical analysis and reporting efforts for major regulatory submissions, resulting in marketing approvals for a number of prescription drug products. He has considerable regulatory experience, having served as sponsor statistical representative at six Food and Drug Administration advisory committee meetings and numerous other regulatory agency meetings.