FDA Application of AI for Precision Medicine Fellowship

About the role

This fellowship applies artificial intelligence (AI) and machine learning (ML) to advance precision medicine by analyzing data within the Center for Drug Evaluation and Research (CDER) drug submission database. It aims to modernize CDER’s data analytics capabilities and support FDA’s mission to protect public health through science-based drug evaluation.

Responsibilities

• Collaborate with multidisciplinary FDA scientists in clinical pharmacology, clinical, data science, and regulatory review to investigate how AI/ML can uncover patterns across regulatory submission data to enhance understanding of drug response variability.
• Curate and preprocess structured and unstructured submission data for model development.
• Apply AI methods to identify key clinical and biomarker features that drive response to therapy.
• Contribute to manuscripts, reports, and presentations that communicate findings to internal and external audiences.
• Support the development of reproducible analytic pipelines that can be reused for future regulatory science projects.

Requirements

The candidate should be currently pursuing or have received a bachelor's, 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/ knowledge:

• Skills in at least one programming language (e.g., Python, R)
• Analytical skills

Qualifications

The candidate should have lived in the United States for at least 36 out of the past 60 months.

Skills

Not specified.

Benefits

Not specified.

Pay

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

Schedule

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

Contact Information

Mentor: Qi Liu (qi.liu@fda.hhs.gov)

Email: ORISE.FDA.CDER@orau.org