*Applications will be reviewed on a rolling-basis.
A bioinformatics research opportunity is currently available with the Office of New Drugs/Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
This project is a collaborative effort between multiple CDER offices and will provide critical information to FDA/CDER regarding the practical application of Next Generation Sequencing (NGS) from tissue acquisition to patient outcome. Through multiple collaborations (including with Johns Hopkins University and the National Cancer Institute), we will assess the use of NGS technology to answer critical research questions in cancer such as drug-induced adverse events and patient-specific indicators of disease or outcome. The main objective of this program is to assess critical parameters involved in the adoption of NGS technology for cancer care. These parameters include but are not limited to tissue processing, laboratory protocols, bioinformatics and variant calling, data processing and related statistical analyses.
Under the guidance of a mentor the participant will be involved in the following:
- analyzing various bioinformatics approaches to understand best-in-practice NGS analytics and novel methodologies
- examining current SOPs and protocols and emerging tools to understand best-in-practice approach for NGS analysis and downstream bioinformatics
- collaborating with a multi-disciplinary team including clinicians, sequencing biologists, programmers, and regulators, and engage with multiple investigators for individual projects
This project is critical to our public health mission and will prepare the participant for a successful career transition into regulatory science research.
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.