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 in clinical data analysis with randomized controlled trials and observational studies. During this time, he has worked as a statistician in the oncology, gastrointestinal, nephrology, musculoskeletal, and immuno-inflammation therapy areas, designing clinical trials, surveys, and observational studies; writing protocols and statistical analysis plans; performing statistical analyses; and supervising permanent staff and contractors. Mr. McSorley has extensive experience in the analysis of comparative studies using categorical data methods, nonparametric statistics, multiple comparisons procedures, and generalized linear mixed models, as well as formulating and implementing analysis plans for observational studies and patient registries using propensity score methods. 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.