Rochester, Minnesota




Fang-Shu Ou, Ph.D., is a biostatistician specializing in clinical trials and survival analysis for cancer. She is a faculty statistician for the Alliance for Clinical Trials in Oncology, leading several gastrointestinal phase III clinical trials that aim to improve future 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 as well as assimilating these new methods in practice.

Focus areas

  • Biomarker discovery. In the era of individualized medicine, novel biomarkers are needed to better guide patient treatments. Dr. Ou collaborates with scientists to evaluate whether mutation detected from cell-free DNA or protein level detected in plasma can be used to achieve this goal.
  • Clinical trials. By leading phase II and III clinical trials, Dr. Ou is involved in screening for the potential treatment options for further evaluation and determining whether new regimens provide better survival than the standard of care. Dr. Ou is also working on developing new statistical methods to tackle challenges in trial design specific to immunotherapy and precision medicine.

Significance to patient care

Dr. Ou's hope is that through her work on phase III clinical trials, better cancer treatments can be identified to improve patient care. Her research focus on biomarker development aims to identify biomarkers that can better assign patients to the best treatment options to achieve individualized medicine.


See my publications


Administrative Appointment

  1. Associate Consultant I-Research, Division of Biomedical Statistics and Informatics, Department of Health Sciences Research

Academic Rank

  1. Assistant 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

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