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.