Thomas Gwise

Division Director, Division of Biometrics IX, OTS, CDER
Thomas E. Gwise, Ph.D. is the Director of the Division of Biometrics IX. The Division, which is part of the Offices of Translational Science and Biostatistics in FDA’s Center for Drug Evaluation and Research, provides statistical expertise to the Office of New Drugs and the Oncology Center of Excellence in application review and research related to hematologic drug and therapeutic biologic approval. Biometrics IX has reviewed multiple proposals to use Real World Data in support of hematology product approval. Prior to joining CDER in 2011, Dr. Gwise led a team of statisticians in FDA’s Center for Devices and Radiological Health reviewing diagnostic devices.