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    This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Silver Spring, MD. Positions may be filled in the following Centers: Center for Tobacco Products (CTP), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), Center for Food Safety and Applied Nutrition (CFSAN), Office of Regulatory Affairs (ORA), Office of Operations (OO), Office of Commissioner (OC), and National Center for Toxicological Research (NCTR).

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    The incumbent may perform the following responsibilities: Provide statistical programming and data management support for review of the evidence related to an applicant's claims regarding safety, efficacy and benefit-risk in New Drug Applications (NDAs), Biologic License Applications (BLAs), and supplemental and abbreviated applications (sNDAs; ANDAs); assesses the quality and completeness of submissions; prepares clinical trial analysis datasets; interprets the applicant's programs; assists with communication with applicants regarding specifications for regulatory information requests; validates sponsor results; produces required tables, listings, and figures.

    Analyzes epidemiological/observational data from health records, registries, natural history studies and contract databases to answer review questions concerning the life-cycle safety, efficacy and use of regulated drugs and biologics; assists in designing and producing code for methods development under the Sentinel initiative and other related programs, including Sentinel safety queries and assists in routine surveillance studies.

    S/he assist in applying, documenting and archiving programs, processes, procedures and SOPs for management and handling of review and research data files and databases created and/or used by statistical reviewers for decision support and regulatory science research; assists in developing special-use databases; imports and exports data into specified formats using established fire-walled Agency servers; utilizes tools to facilitate the transformations needed to input clinical trial data into special use databases; assists in integrating data from multiple studies for meta-analytical approaches needed for the study of issues associated with particular classes of drugs and biologics.

    Assist in assessing requirements and planning the design and validation of statistical programming code to apply quantitative and graphical approaches within the regulatory review and research environment. Assist in developing statistical programming solutions across projects and/or technologies to meet internal regulatory review and research needs. Plans and coordinates statistical programming for complex studies; develops, validates, implements, documents, maintains, and supports programming tools and software in accordance with standards and accepted validation procedures. Supports efforts to develop document and apply reusable code and/or tools. Develops software using the appropriate statistical programming packages (e.g., R, JAGS, SAS ) for OB statistical reviewers to support programming intensive review-related activities, such as, sensitivity analysis, Bayesian approaches, clinical trials modeling, genomic studies, psychometric Clinical Outcome Assessment (COA) validation and simulation.

    Travel Required

    Not required

    Supervisory status


    Promotion Potential


    Who May Apply

    This job is open to…

    All U.S. Citizens

    Questions? This job is open to 1 group.

  • Job family (Series)

    1530 Statistics

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/487639300. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.