Program analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications, responses to regulatory questions). Provide statistical programming and validation support for clinical study reports, oversee external vendors (e.g., CROs), and coordinate programming activities with Biometrics lead, data managers, and other study programmers.