The Government Health and Safety Solutions Operation is seeking a Lead Epidemiologist, contingent upon contract award, in the Silver Spring, MD area.
The Sentinel Contract supports the Food and Drug Administration (FDA) organization's long-term initiative to create a national electronic system for monitoring FDA-regulated medical product safety in alignment with FDA's mission to protect the public health. The contract supports strengthening the core capabilities of Sentinel as it evolves to meet emerging business needs and expands the FDA's capabilities of post-market surveillance of approved medical products.
This position is contingent upon contract award.
Specific roles & responsibilities for the Lead Epidemiologist position include but not limited to the following:
Contribute epidemiological expertise to multi-project efforts involving safety assessments of drugs using FDA's Sentinel Initiative. Utilize a variety of surveillance tools including adverse event report data, published scientific literature, and preclinical, clinical, and pharmacologic knowledge. Provide innovative approaches whenever possible. Lead projects focused on conducting and improving active drug safety surveillance using the Sentinel System, conducting epidemiologic studies using observational data resources. Ensure the proposed and ongoing projects meet the best practices in epidemiology. Serve as subject matter expert for the observational data aspects of the use of real world evidence.
• EDUCATION & EXPERIENCE: Requires minimum 5 years of experience with a Master's degree in epidemiology, public health, or relevant field. PhD in epidemiology, public health, or relevant field is preferable.
• Expert knowledge of the drug development process and US regulatory requirements.
• Experience evaluating safety signals that arise by putting them into the context of drug use including calculating reporting rates, the existing body of evidence in the scientific literature,
• Involvement in FDA-sponsored epidemiologic studies needed to quantify and characterize drug safety risks detected through spontaneous reports or through systematic review of the scientific literature.
• Experience in analyzing biomedical, behavioral epidemiological data, or similar scientific literature, research findings and data.
• Evidence of successful management of pharmaco-epidemiological, biomedical, social sciences, behavioral epidemiological projects related to conducting and supporting high quality observational studies capable of informing regulatory decision making.
• Experience utilizing data extracted from electronic health records
• Demonstrated current and significant relationships with FDA executives
• FDA customer experience and knowledge of their organizational structure
• Experience with successful deliverables in other FDA-sponsored pharmaco-epidemiology contracts involving analyses of longitudinal healthcare data