FDA Bioinformatics Fellowship

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available in the Office of New Drugs/Immediate Office, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

Research Project: This project in the Office of New Drugs/Immediate Office will research and develop novel, user-friendly software solutions to facilitate the review of toxicology study data by FDA CDER pharmacology/toxicology reviewers. The methods developed may potentially be incorporated into existing software tools or a new platform may be developed to deploy and maintain these custom Standards for Exchange of Nonclinical Data (SEND) data analysis/visualization tools. The project will enhance the ability of FDA/CDER reviewers to leverage electronic SEND datasets to improve both the thoroughness and efficiency of their review process.

Learning Objectives: Under the guidance of a mentor, the participant will be trained on the following topics:

• The fundamentals of how FDA CDER reviewers interpret toxicology study results
• The SEND data standard and how it maps onto toxicology study design and results
• Development of R scripts to analyze and visualize toxicology study results encoded in SEND datasets
• Deployment of R Shiny-based web applications to aid in the analysis and visualization of toxicology study data

Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation: The appointment is full time.

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 have received or be currently pursuing a bachelors, master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. 

Preferred skills:

• Strong organizational, analytical, interpersonal, and research skills in biology, pharmacology, toxicology, or a related field of biomedical science
• Familiarity with R, Python, MATLAB, Perl, JavaScript, Java, or a similar programming language to analyze and visualize scientific data; and R to develop interactive data visualization applications via the Shiny package

Eligibility Requirements

• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or currently pursuing.
• Academic Level(s): Graduate Students, Post-Bachelor's, Postdoctoral, Post-Master's, or Undergraduate Students.