FDA Modeling and Simulation Fellowships

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 33,480 - 44,640; Full time

Benefits offered by this job

Competitive stipend based on educational level

Opportunity to work with FDA experts

Job summary

A research institute seeks candidates for a project within the FDA focusing on quantitative analysis and modeling. This opportunity requires a master's or doctoral degree in relevant fields, such as data science or engineering. The role includes conducting simulations for bioequivalence and using AI to enhance research methods. The selected candidate will receive a competitive stipend and should be a U.S. citizen or lawful permanent resident. Start date is flexible between March and April 2026.

Qualifications

• Currently pursuing or received a master's or doctoral degree in a relevant field.
• Disciplines include computer science, artificial intelligence, and data science.
• Affirmation of living in the US for at least 36 of the past 60 months.

Responsibilities

• Conduct modeling and simulation of solid oral products for bioequivalence.
• Apply artificial intelligence for business intelligence in the Agency.
• Build data infrastructure to improve ANDA review efficiency.

Skills

Quantitative analysis

Modeling and simulation

Data analysis

Artificial Intelligence

Machine Learning

Education

Master's or Doctoral Degree in a relevant field

Job description

How To Apply

To submit your application, scroll to the bottom of this opportunity and click APPLY.

All documents must be in English or include an official English translation.

• An application
• Transcripts – 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

If you have questions, send an email to [e-mail]. Please include the reference code for this opportunity in your email.

Application Deadline: 3/30/2027 3:00:00 PM Eastern Time Zone

Description

Applications will be reviewed on a rolling‑basis.

FDA Office and Location

Multiple research opportunities are currently available within the Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD), located within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in Silver Spring, Maryland. The CDER performs an essential public health task by ensuring that safe and effective drugs are available to improve the health of people in the United States.

The DQMM provides expertise in advanced quantitative methods for the generic drug research program and conducts regulatory science and research activities based on quantitative approaches, including providing quantitative method support for guidance development, abbreviated new drug application (ANDA) reviews, citizen petitions, controlled correspondence, pre‑ANDA meetings, methodology development for bioequivalence evaluation, active ingredient sameness demonstration, and post‑marketing safety surveillance.

Research Project

This research project in DQMM will provide an outstanding opportunity to learn and apply quantitative analysis, modeling, and simulation.

Learning Objectives

• Modeling and simulation of solid oral products to ensure consistency and quality of bioequivalence (BE) recommendations (e.g., physiologically based pharmacokinetic (PBPK) absorption models, in vitro‑in vivo correlations and pharmacokinetic/pharmacodynamic (PK/PD) modeling) including biowaivers.
• Modeling and simulation to reduce/replace in vivo BE studies (i.e., in vivo PK BE studies, clinical endpoint or pharmacodynamic endpoint BE studies) for complex generic products and other generic products with clinical study challenges.
• Application of PBPK and/or computational fluid dynamics models to develop new BE methods for locally acting drug products administered via non‑oral routes.
• Population PK modeling to support more effective in vivo study designs and methods for evaluating BE, including implementing sparse sampling schemes for oncology patient studies and developing alternative study designs for long‑acting injectable products with shorter durations or reduced sample sizes.
• PK/PD modeling of narrow therapeutic index drugs and complex drug products and clinical trial simulation to aid risk‑based BE evaluation.
• Build data infrastructure and analysis tools to increase ANDA review efficiency and quality.
• Use and development of artificial intelligence (AI), machine learning (ML) and large language models (LLMs) to help promote business intelligence in the Agency (e.g., interactive AI expert systems).
• Integration of AI/ML models with conventional/mainstream PK modeling to improve the modeling efficiency (e.g., automatic PK model selection, ML based survival analysis, etc.).
• Applications and development of data analytic approaches to support complex generic drug product development and regulatory assessment, e.g., whole profile comparison, multivariate analysis, etc.

Mentor

The mentor for this opportunity is Andrew Babiskin ([e-mail]). If you have questions about the nature of the research, please contact the mentor.

Appointment Details

Anticipated Appointment Start Date: March/April 2026 (flexible).

Appointment Length: Initially for one year, may be renewed upon recommendation of FDA and contingent on the availability of funds.

Level of Participation: 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.

Background Investigation

Completion of a successful background investigation by the Office of Personnel Management (OPM) is required for an applicant to be onboarded at FDA. OPM can complete a background investigation only for individuals, including non‑U.S. Citizens, who have resided in the U.S. 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 a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest, or a relationship with an SRO, and does not voluntarily divest or terminate the relationship, then the individual is not eligible for placement at FDA.

Education

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of the start date. The agreement covers such topics as:

• 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;
• Research materials and laboratory notebooks are the property of the FDA;
• Obligation to protect and not disclose non‑public information.

Qualifications

• Currently pursuing or have received a master’s or doctoral degree in a relevant field (degree received within the last five years of the appointment start date);
• Discipline(s) may include computer, information, and data sciences; artificial intelligence; computer science; data science; information science and technology; scientific computing and informatics; engineering; life health and medical sciences; mathematics and statistics; physics;
• Affirmation: have lived in the United States for at least 36 of the past 60 months and have read the FDA Ethics Requirements.

Point of Contact

Ashley

Eligibility Requirements

• Master’s or Doctoral Degree received within the last 60 months or currently pursuing;
• Relevant disciplines as listed under Qualifications;
• Affirmation of U.S. residency and ethics reading.