The Division of Pediatric and Maternal Health at the FDA in collaboration with
the Division of Psychiatry is seeking a fellow who is interested in working on
a regulatory science project.
Up to 42% of recently completed pediatric trials have failed to establish
either safety or efficacy, with the majority failing to establish efficacy,
leading to an inability to label the product for use in children. The project
is a retrospective review and analysis of patient level data (adult and
pediatric) from new drug applications (NDAs) to explore trial design elements
or conduct that may contribute to the negative findings and provide a framework
for optimizing trial design for future pediatric drug development.
Under the guidance of mentors with clinical, regulatory and statistical
expertise, the participant will gain knowledge in trial design considerations
that can impact response in drug development. In addition, the participant
will learn about methodological features of studies, data curation and database
building, data analysis, dissemination of results (presentations,
publications), etc.
Opportunities are available for current students in a Ph.D. or other
professional doctorate program and graduates with a doctoral degree in
statistics, pharmacometrics, etc.
Interested applicants should apply directly using the link below:
https://www.zintellect.com/Opportunity/Details/FDA-CDER-2020-0575
Lily Mulugeta, PharmD
[email protected]<mailto:[email protected]>
Associate Director, Policy and Research
Division of Pediatric and Maternal Health
Office of New Drugs, CDER, FDA