Statistician Jobs in CDER
Description of Duties
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Work with the review team to:
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provide statistical programming and data management support;
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assess the quality and completeness of submissions;
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prepare clinical trial analysis datasets;
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interpret the applicant's programs;
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assist with communication with applicants regarding specifications for regulatory information requests;
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validate sponsor results;
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produce required tables, listings, and figures;
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assist in modeling and simulation;
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suggest possible additional statistical analyses required to fully evaluate the evidence in the submission.
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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.
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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.
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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:
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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:
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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.