Dr. Bob Yan

Senior Vice President, Biostatistics and Statistical Programming, Clinical Service Center

Ph.D. of Statistics, the University of Illinois at Chicago;

MBA, the University of Chicago, Business School.

Over 28 years of experience in biostatistics in the clinical research area, with more than 21 years of team management experiences.

Previously served at Abbott and Astellas, as the head of the biostatistics and statistical programming departments. And, then held the head position of the statistical department for the Asia-Pacific region at PAREXEL. After PAREXEL, as the head of statistical programming department at Sanofi, in China.

Extensive experience in NDA submissions and communication with FDA/NMPA for Pre-IND and Pre-NDA discussions.

Member of the CDE (Center for Drug Evaluation) Biostatistics Guidance Development Committee. Participated in the compilation of all the statistical Guidance Principles, released by NMPA, involving discussing, drafting, editing, since 2019. Provided multiple training sessions on biostatistics for CDE medical reviewers, or evaluator.

Expertise at non-clinical and clinical phase I-IV trial projects in therapeutic areas such as cardiovascular, pain management, asthma, diabetes, oncology, nephrology, and Alzheimer's disease.