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ORISE Fellowship Opportunity at the FDA

From: Mulugeta, Yeruk <Yeruk.Mulugeta>
Date: Tue, 25 Aug 2020 16:32:12 +0000

The Division of Pediatric and Maternal Health at the FDA in collaboration w=
ith the Division of Psychiatry is seeking a fellow who is interested in wor=
king on a regulatory science project.

Single arm, uncontrolled studies are used in approximately 25% of pediatric=
 drug development programs and 63% of rare disease trials. Single arm trial=
s are often difficult to interpret. This project proposes that patient-leve=
l matching approaches like propensity scores can be used with historical cl=
inical trial data to create a synthetic control arm to improve context for =
the interpretation of single arm trials.

The participant will gain extensive knowledge on methodological approaches =
used with historical clinical trial data to create a synthetic control arm.=
 In addition, the participant will gain experience in review of methodologi=
cal 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 profes=
sional doctorate program and graduates with a doctoral degree in statistics=
, pharmacometrics, etc.

Interested applicants should apply directly using the link below:

Lily Mulugeta, PharmD

Associate Director, Policy and Research
Division of Pediatric and Maternal Health
Office of New Drugs, CDER, FDA

Received on Tue Aug 25 2020 - 12:32:12 EDT

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