Description of Duties
- Evaluate and advise on protocols for clinical studies and assess the evidence for safety and efficacy from clinical studies submitted in drug and biologics applications
- Employ a broad variety of statistical procedures relevant to pre-clinical and clinical evaluation decisions for new and generic drugs as well as new and biosimilar biologics and the emerging fields of quantitative risk assessment and pharmacogenomics.
- 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.
- Refine your consulting, communication, and presentation skills.
- Engage in an active regulatory research program which will allow you to advance your skills and professional development.
- Interact with national, international, public, and private organizations on statistical issues, and help develop guidance for the pharmaceutical industry.
- An advanced degree that includes 24 total semester hours of mathematics and statistics, including at least 12 hours in mathematics and 6 hours in statistics.
Grade (Salary) Levels
- GS-11/12/13 at the headquarters and field offices.