Sue-Jane Wang, PhD
Biomarker Lead/Liaison and Deputy Division Director in the Office of Biostatistics, U.S. Food and Drug Administration, USA
Dr. Sue-Jane Wang has been the Biostatistics Lead and Liaison to FDA/CDER Biomarker Qualification Program for Office of Biostatistics (OB) in the Office of Translational Sciences, CDER, US FDA. Sue-Jane is also the Deputy Director for Division of Biometrics I in OB. She is an FDA senior expert statistician since 2004 and has served as OB Associate Director for Adaptive Design and Pharmacogenomics for a decade. She is well-recognized nationally and internationally for her significant contributions to Biopharmaceutical Statistical Community on adaptive designs, biomarkers, pharmacogenomics and medical imaging. In her various roles, Dr. Wang has been a distinguished faculty for CDER and has been contributing to FDA clinical, statistical, biomarker and co-development guidance. She is a member of FDA-NIH Biomarker Working Group and FDA Omics-One Health co-chair. Dr. Wang has been active in research covering complex trial design, pharmacogenomics, biomarker, medical imaging, theranostics, and in professional editorships, with more than 100 peer reviewed publications. She has been awarded for her professional recognitions including, e.g., a Fellow of the American Statistical Association, Thomas Teal Award for Excellence in Statistics Publishing awarded by Drug Information Association, an FDA Level Scientific Achievement (Individual) Award on Excellence in Analytical Science.