FDA Evaluation of Reproductive Therapies Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of Translational Sciences/Office of Biostatistics at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The Office of Biostatistics is recognized for excellence in the application and communication of statistical science in drug regulation and development. We play a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life-cycle. To support CDER’s mission, we provide statistical leadership, expertise, and advice to ensure that safe and effective drugs are available to the American people.
This project seeks to determine whether there are more distal endpoints than clinical pregnancy that could reliably predict live births during Assisted Reproductive Technology (ART) procedures in women. The project will determine if one or more parameters could be used as endpoints in future clinical trials for drug, biologic and biosimilar products that are seeking an indication of treatment of women undergoing ART therapy.
Under the direction and guidance of a mentor, the participant will be involved in the following opportunities:
- Learning how to access the Center for Disease Control (CDC) database
- Evaluating the database structure
- Writing code for consolidating the relevant data for the project objective
- Creating analysis data files
- Writing statistical analysis plans to handle potential statistical issues related to such health related databases
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.