Dr. Kui Shen, Senior Director of Clinical Statistics, Bayer

Dr. Kui Shen is a Senior Director of Clinical Statistics at Bayer. He obtained his Ph.D. from a joint program between the University of Pittsburgh and Carnegie Mellon University.

Dr. Shen leads a broad portfolio of responsibilities, including serving as Clinical Project Statistician across multiple compounds, companion diagnostics, biomarker studies, and the development of AI algorithms for clinical development. He led the statistical development of the company’s first companion diagnostics global submission and has overseen highly complex genetic studies supporting both EMA and FDA drug submissions. In addition, he is actively advancing novel trial design methodology, including biomarker-adaptive trial designs and deep learning algorithms for time-to-event endpoints.

An active leader in the precision medicine community, Dr. Shen serves as an Executive Committee Member of the American Statistical Association (ASA) Section on Statistics in Genomics and Genetics (SSGG) and as Chair of the Precision Medicine Statistics Working Group under the ASA Biopharmaceutical Section.