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Kun He, PhD

Advisory Board Member

Kun He, Ph.D., is the Chief Statistician of R&G US Inc. He provides regulatory, clinical, and statistical sciences consulting to pharmaceutical and biotech companies, serves on the independent Data Monitoring Committee for global trials, and participates in developing regulatory guidance for the Center for Drug Evaluation of the National Medical Products Administration. Before joining R&G in 2019, he worked at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration for 20 years, most recently serving as Associate Division Director of the Division of Biometrics V, supporting the Office of Hematology and Oncology Products. During his FDA tenure, he reviewed thousands of INDs, including I-SPY2, Lung-Map, and GBM Agile, and hundreds of NDA/BLAs, including the initial approvals of Yervoy, Keytruda, Opdivo, Bavencio, and Libtayo. Prior to joining the FDA in 1999, he served on the faculties of the University of Kansas and the University of Minnesota.

Dr. He received a BS in Mathematics from the University of Science and Technology of China, a MS in Statistics from Peking University, and a Ph.D. in Statistics from Cornell University.