FDA Data Science Fellowship - Bioinformatics and AI/Machine Learning

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is currently available in the Office of Biostatistics and Pharmacovigilance (OBPV) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.

Research Project: The fellow will contribute to the development of novel scientific, bioinformatics, and AI/machine learning algorithms, as well as the adaptation and optimization of existing tools. This research aligns with CBER’s efforts to enhance the development, operations, and management of FDA’s High-performance Integrated Virtual Environment (HIVE) infrastructure and scientific computing environment.

The opportunity involves building and improving applications that compute, analyze, and interpret biological and scientific data, including large-scale omics datasets, within high-performance computing (HPC) environments.

Learning Objectives: Under the guidance of a mentor, you will gain skills in and learn to:

• Develop and implement novel scientific, bioinformatics, and AI/ML algorithms
• Optimize and adapt existing analytical tools for performance and scalability
• Suggest and implement new software solutions and computational tools
• Maintain, support, and test applications for bugs, redundancies, and security issues
• Standardize and automate application-level processes
• Maintain and improve components of the bioinformatics and AI-focused HPC environment
• Gain experience working with large-scale biological datasets, including genomics, transcriptomics (bulk and single-cell), and proteomics data

Mentor: The mentor for this opportunity is Luis Santana-Quintero (luis.santana-quintero@fda.hhs.gov ) If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors.

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.

Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience. 

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.