This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Silver Spring, MD. Positions may be filled in the following Centers: Center for Tobacco Products (CTP), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), Center for Food Safety and Applied Nutrition (CFSAN), Office of Regulatory Affairs (ORA), Office of Operations (OO), Office of Commissioner (OC), and National Center for Toxicological Research (NCTR).Learn more about this agency
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
Additional selections may be made within the same geographical area FDA-wide.
The incumbent may perform the following responsibilities: Collaborates with statistical reviewers and management on a variety of computationally intensive projects to support and improve the efficiency of regulatory product review and applied regulatory research. The incumbent works with multidisciplinary teams of scientists and a diverse array of stakeholders in a dynamic, highly challenging, and innovative atmosphere.
Working with division's management, team leaders and statistical reviewers, the incumbent plays a critical role in supporting the mission of advancing the product review process.
Works with the team leader and the statistical reviewer to provide statistical programming and data management support for review of the evidence related to an applicant's claims regarding safety, efficacy and benefit-risk in New Drug Applications (NDAs), Biologic License Applications (BLAs), and supplemental and abbreviated applications (sNDAs; ANDAs); assesses the quality and completeness of submissions with assistance from team leader and/or reviewer; prepares clinical trial analysis datasets; assists with communication with applicants regarding specifications for regulatory information requests; validates sponsor results; produces required tables, listings, and figures
As requested by senior staff, assists in analyzing epidemiological/observational data from health records, registries, natural history studies and contract databases to answer review questions concerning the life-cycle safety, efficacy and use of regulated drugs and biologics; assist in designing and producing code for methods development under the Sentinel initiative and other related programs, including Sentinel safety queries and assists in routine surveillance studies.
Assists in applying, documenting and archiving programs, processes, procedures and SOPs for management and handling of review and research data files and databases created and/or used by OB statistical reviewers for decision support and regulatory science research; assist in developing special-use databases; imports and exports data into specified formats using established fire-walled Agency servers; assists in implementing transformations needed to input clinical trial into data special use.
Who May Apply
This job is open to…All U.S. Citizens
Job family (Series)
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/487638800. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.