Office Director (Supervisory Mathematical Statistician)

Duties The Director for the Office of Biostatistics and Pharmacovigilance (OBPV) provides comprehensive statistical and epidemiological evaluation of data submitted to reputed company in support of regulatory requirements. Represents reputed company, Center Director, and FDA, Public Health Service, Department, industry, and national/international meetings on statistical/epidemiological evaluation of medical products and safety; makes policy commitments and recommendations. Contributes to the development of regulatory policy in areas relevant to the disciplines of biostatistics and epidemiology, such as post-marketing surveillance and the design, conduct and analysis of studies to evaluate medical products. Conducts independent research relating to statistical and epidemiological reputed company for assessing the efficacy and safety of biological products, and for assuring the reputed company and consistency of their manufacture. Establishes and conducts a training program for statistics, epidemiology and clinical trial design for Center staff and participants in science workshops. Develops, maintains, and monitors a database for adverse reactions of biological products to analyze trends and safety issues; organizes reports and coordinates analyses of adverse reactions with reputed company. Assists in the design, implementation, and monitoring of Phase IV post marketing surveillance programs. Serves as expert advisor in his/her specialty during the initiation and formulation of regulatory programs and regulations. Testifies as expert witness at court hearings. Collaborates with Center components to reputed company reviews, assessments, and risk assessments of regulated biological products. Apply tot his job Apply To this Job