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Biostatistics

Oak Ridge Institute for Science and Education (ORISE), Silver Spring, Maryland

Position Description:

*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.

Qualifications:

The qualified candidate should have received a doctoral degree in Computer Sciences, Life Health and Medical Sciences, Mathematics, Statistics or a related field, 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:
  • Knowledge of biostatistics
  • Modeling and programming skills
  • Prior experience with clinical trials especially oncology trials
  • Excellent written and oral communication skills
     

To Apply:

Apply at: https://www.zintellect.com/Opportunity/Details/FDA-CBER-2020-0031

A complete application consists of:
  • An application
  • Transcript(s) – For this opportunity, an unofficial transcript or copy of the student academic records printed by the applicant or by academic advisors from internal institution systems may be submitted. All transcripts must be in English or include an official English translation. Click here for detailed information about acceptable transcripts.
  • A current resume/CV, including academic history, employment history, relevant experiences, and publication list
  • One educational or professional recommendation

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 (FDA-CBER-2020-0031) in your email.

Application Deadline: September 21, 2020 3:00PM EST

 

This post will be available until July 14, 2020 or until filled.

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