About FDA

Statistician Jobs in CDER


Description of Duties

  • Work with the review team to:
    • provide statistical programming and data management support;
    • assess the quality and completeness of submissions;
    • prepare clinical trial analysis datasets;
    • interpret the applicant's programs;
    • assist with communication with applicants regarding specifications for regulatory information requests;
    • validate sponsor results;
    • produce required tables, listings, and figures;
    • assist in modeling and simulation;
    • suggest possible additional statistical analyses required to fully evaluate the evidence in the submission.
  • Employ a broad variety of statistical procedures relevant to pre-clinical and clinical evaluation of efficacy and safety for new and generic drugs and biologics.
  • Work with multidisciplinary teams of review scientists in a dynamic, highly challenging, and innovative atmosphere of development, evaluation, and research of drug and therapeutic biologics.
  • Applying your skills to address unique and precedent setting problems, while refining your consulting, communication, and presentation skills.

Qualifications Basic requirements for all grades in this position include:

  • A degree that includes 15 total semester hours of mathematics and statistics, including at least 6 hours in statistics and 9 hours in mathematics or related fields.

Grade (Salary) Levels Level at which Statistician positions are commonly filled are:

  • GS-9/11/12/13 at the headquarters and field levels.

Geographical Location

Statisticians (Statistical Analysts) are located at HQ (suburban Washington, D.C.) and in facilities throughout the U.S.


Page Last Updated: 09/25/2018
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