FDA Data Mining in Cardiovascular Safety Model Development

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Stipend

Job summary

FDA offers a research opportunity in the Office of Translational Sciences (OTS), OCP, DARS, CDER, located in Silver Spring, MD. A doctoral degree is required, and the appointment emphasizes data mining, regulatory science methods, and collaborative translational work in cardiovascular safety data analysis.

The program is full-time with a monthly stipend and potential manuscript authorship. The learning objectives include gaining knowledge of FDA regulatory policies, developing data mining and

Qualifications

• Degree: Doctoral Degree.
• Regulatory science experience or interest in cardiovascular safety.
• Data mining and database development in regulatory context.
• Collaborative research in translational science and pharmacology.

Responsibilities

• Contribute to data mining and database development for cardiovascular safety datasets.
• Apply statistical modeling and computational tools to cardiotoxicity endpoints.
• Collaborate with FDA scientists to inform regulatory strategies.
• Present findings at internal and external conferences and contribute to manuscripts.

Education

Doctoral degree in Chemistry and Materials Sciences

Discipline: Computer, Information, and Data Sciences

Discipline: Life Health and Medical Sciences

Discipline: Mathematics and Statistics

Discipline: Physics

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0160

Description

• Applications will be reviewed on a rolling-basis.

FDA Office and Location

A research opportunity is available in the Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Division of Applied Regulatory Science (DARS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA), located 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. These efforts cover more than just medicines.

Research Project

This research opportunity supports data mining and database development efforts in the cardiovascular safety space, with a focus on advancing regulatory science through systematic analysis of nonclinical and clinical cardiotoxicity data. You will contribute to the development and curation of comprehensive databases designed to evaluate the current landscape of cardiovascular safety data used in drug development and regulatory decision-making.

You will investigate and apply advanced data mining techniques, statistical modeling, and computational tools to identify patterns, gaps, and trends across large datasets relevant to cardiac safety including human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) data, ion channel pharmacology, in vivo and clinical QT data, and other cardiotoxicity endpoints. Through this, you will collaborate with FDA scientists to analyze how real-world and experimental data can be leveraged to inform translational regulatory strategies.

This research will contribute to the development of innovative approaches for integrating large-scale cardiovascular safety datasets into the regulatory review process, advancing FDA's regulatory science mission and public health objectives.

Learning Objectives

• Gain comprehensive knowledge of FDA regulatory policies and regulations regarding the evaluation of cardiovascular safety of new drugs
• Develop experience in data mining methodologies, database construction, and statistical analysis applied to cardiotoxicity datasets, including hiPSC-CM, ion channel, QT, and related cardiovascular safety data
• Gain hands-on experience with computational tools and programming languages relevant to large-scale data analysis, including data visualization and reproducible research practices
• Collaborate with interdisciplinary teams to investigate translational approaches that bridge nonclinical and clinical cardiovascular safety data
• Present research findings at internal and external scientific conferences, contributing to the broader regulatory science community
• Participate in writing scientific manuscripts that advance the field of cardiovascular safety assessment

You will gain comprehensive knowledge of FDA regulatory policies and regulations regarding the evaluation of safety and efficacy of new drugs, along with hands-on experience in regulatory science methodologies.

Mentor

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

Anticipated Appointment Start Date

September 1, 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.

Qualifications

The qualified candidate should be currently pursuing or have received a doctoral degree in the one of the relevant fields.

Point of Contact

Ashley

Eligibility Requirements

• Degree: Doctoral Degree.
• Discipline(s):
  • Chemistry and Materials Sciences
    • Analytical Chemistry
    • Bio-inorganic Chemistry
    • Bio-organic Chemistry
    • Biophysical Chemistry
    • Chemistry (General)
    • Environmental Chemistry
    • Inorganic Chemistry
    • Materials Sciences
    • Organic Chemistry
    • Physical Chemistry
    • Polymer Chemistry
    • Theoretical Chemistry
  • Computer, Information, and Data Sciences (17)
    • Earth and Geosciences (1)
    • Engineering (29)
    • Life Health and Medical Sciences (51)
    • Mathematics and Statistics (11)
    • Physics (16)

Affirmation

I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)