Rochester, Minnesota




Fang-Shu Ou, Ph.D., is a biostatistician at Mayo Clinic who specializes in clinical trials and survival analysis for cancer. She also is a faculty statistician for the Alliance for Clinical Trials in Oncology, leading several gastrointestinal phase 3 clinical trials that aim to improve patient care. Dr. Ou is also the group statistician for Academic and Community Cancer Research United, which provides clinical trial opportunities to the community. Her research interest is in survival analysis, with the goal of developing new statistical methods for clinical trial design and analysis and assimilating these new methods into practice.

Focus areas

  • Biomarker discovery. In the era of individualized medicine, novel biomarkers are needed to better guide patient treatments. Dr. Ou collaborates with other scientists to evaluate whether mutations detected from cell-free DNA or protein levels detected in plasma can be used to achieve this goal.
  • Clinical trials. By leading phase 2 and 3 clinical trials, Dr. Ou is involved in assessing the efficacy of new agents and aims to provide better treatment options for patients. Dr. Ou is also working to develop new statistical methods to tackle challenges in clinical trial design specific to immunotherapy and precision medicine.

Significance to patient care

Dr. Ou focuses on conducting statistical research on topics arising from collaborative studies to advance the design and conduct of clinical trials. Dr. Ou hopes that her methodological research and her work on phase 3 clinical trials will identify better cancer treatments to improve patient care.


Primary Appointment

  1. Division of Clinical Trials and Biostatistics, Department of Quantitative Health Sciences

Academic Rank

  1. Associate Professor of Biostatistics


  1. Ph.D. - Biostatistics University of North Carolina at Chapel Hill
  2. MS - Statistics University of Wisconsin - Madison
  3. BS - Management Science National Chiao Tung University

Mayo Clinic Footer