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    Duties

    Summary

    This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Biostatistics (OB). The mission of the Office of Biostatistics is to provide statistical leadership, expertise, and advice to foster the expeditious development of safe and effective drugs and therapeutic biologics for the American people and to protect the public health.

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    Responsibilities

    • Provide scientific expertise and recommendations to multi-disciplinary scientific/medical regulatory teams in FDA on advanced statistical, mathematical, and computational theory and practices.
    • Meet with industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within the area of review.
    • Prepare comprehensive studies and integrated discussions of data submitted for review and other available information.
    • Submit substantive regulatory recommendations and conclusions for concurrence by the scientific supervisor.
    • Apply mathematical and statistical theories, techniques and methods in the review, evaluation, and analysis of scientific submissions .

    Travel Required

    Not required

    Supervisory status

    No

    Promotion Potential

    14

  • Job family (Series)

    1529 Mathematical Statistics

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This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/517626200. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.