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