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.

Qualifications

• 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 Level at which Mathematical Statistician positions are commonly filled are:

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

Geographical Location