FDA Evaluation of Estimands for Ophthalmic Products Fellowship

Application Deadline

3/29/2024 3:00:00 PM Eastern Time Zone

Description

*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). This project will conduct an evaluation of the extent and the type of intercurrent events that are commonly encountered for selected indications using submissions to date. This project will also conduct a simulation study to evaluate the impact of different strategies and methods of analysis on the evaluation of clinically meaningful estimands for regulatory approval of Ophthalmic drugs.   

Under the guidance of the mentor the participant will be introduced to real life research problems and will receive guidance throughout the duration of the research project on how to conduct regulatory research. The participant will gain familiarity with the application of the estimand framework for the design and analysis of clinical trials in Ophthalmology which could also be extended to other indications.

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 Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA.   For additional requirements, see FDA Ethics for Nonemployee Scientists.

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:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

Qualifications

The qualified candidate should be currently pursuing or have received a Doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. 

Preferred skills:

Prior experience with clinical trial design and analysis and some understanding of the estimand framework.

Eligibility Requirements

• Degree: Doctoral Degree received within the last 60 months or currently pursuing.