The FDA Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance (OBPV), CBER Surveillance Program (CSP) is offering an opportunity for an Epidemiologist.
CBER is responsible for regulation of biologic products including vaccines; allergenics; blood components and blood-derived products; tissues; and cell, gene and advanced therapeutics.
As a member of the CBER Surveillance Program Team, the candidate will work with OBPV and other CBER staff to identify key post-market safety and effectiveness questions to be assessed by the CBER active surveillance program called the BEST Initiative including design and implementation of observational studies.
MAJOR DUTIES A. Participate in design and execution of observational studies using large-scale health care data (administrative claims and electronic health records), interpretation of results, preparation of study reports and manuscripts for publication B. Utilize results of observational studies to contribute to regulatory decisions C. Participate in expanding the infrastructure and capacity for the BEST Initiative
DESIRED KNOWLEDGE AND EXPERIENCE • A doctoral degree in epidemiology • Proficiency in epidemiologic and statistical methods • Strong analytical skills along with written and oral communication skills • High level of interpersonal skills to interact and negotiate with many different stakeholders • Experience or training in pharmacoepidemiology preferred but not required • Applications will be accepted from all groups of qualified candidates, including U.S. Citizens. Non-U.S. Citizens holding valid immigration status and work authorization may apply for staff fellowship appointments.
INTERESTED? Send us an email (FDABEST@fda.hhs.gov) and tell us about your special attributes; be sure to attach your resume or curriculum vitae.