A complete application consists of:
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available with the Office of Biostatistics and Epidemiology (OBE), at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
Under the guidance of a mentor, the selected participant will participate in the development of innovative design and analysis strategies for immune-oncology (IO) trials. Specifically, the goal of this project is two-fold: first, to develop innovative approaches to ensure adequate study power for IO trials and reduce the risk of false-negative finding; second, to enhance IO trial efficiency and mitigate the occurrence of non-proportional hazards (NPH) patterns. The participant will be involved in the development and application of novel techniques to develop strategies for trial design and data analysis, as well as perform literature reviews, presentation of research results, and preparation of scientific manuscripts.
Anticipated Appointment Start Date: September 1, 2020
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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
The qualified candidate should have received a doctoral degree in one of the relevant fields, or be currently pursuing the degree and will reach completion by the appointment start date. Degree must have been received within five years of the appointment start date.
Preferred skills:
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