Jian Zhao : The Roles of Statisticians at Center of Drug Evaluation and Research, FDA

Posted by Min Yang , part of the Statistics and Data Science Seminar.

At

April 27, 2022, 4 p.m.

In

Zoom

Abstract

This presentation will describe the roles of statisticians at FDA, Center for Drug Evaluation and Research. High level overview of FDA missions and organizations as well as responsibilities of FDA statisticians in the Office of Biostatistics will be presented. IND and NDA review process will be briefly introduced followed by a review case study for illustration. In addition, a variety of opportunities for statisticians working at FDA including public meetings, guidance & policy development, working groups, research, leadership development, will be discussed.