Statistics Collaborative - Design and analysis for biomedical research


Zi-Fan Yu, Sc.D.
Senior Statistical Scientist

Zi-Fan Yu, Sc.D., joined Statistics Collaborative, Inc. (SCI) in 2003. She is a member of the American Statistical Association, the International Biometric Society (Eastern North American Region), and the Society for Clinical Trials.

At SCI, Dr. Yu has served as the statistician supporting clinical trials run at academic research centers and small biotechnology companies. She has helped sponsors to develop outcome measures for Phase 3 trials by exploring earlier phase data. She provides general consultation on sample size, protocol design, and statistical analysis plan development.

Dr. Yu has experience with the statistical and regulatory issues involved in Phase 2 and 3 registrational clinical trials. She was the statistical lead for the BLA preparations and submission of two Phase 3 orphan–indication trials: rhASB enzyme replacement therapy for MPS-VI (Naglazyme) and, more recently, the AAV2-hRPE65v2 gene therapy to treat inherited retinal diseases caused by mutations in the RPE65 gene (Luxturna). The latter was a co-recipient of the 2017 Trial of the Year Award by the Society for Clinical Trials. She has also supported a Pre-Market Approval (PMA) application for a device to treat thoracic aortic aneurysms.

Dr. Yu has experience serving as the independent reporting statistician for Data Monitoring Committees (DMCs) overseeing multinational Phase 3 trials in oncology, lung disease, diabetes, cardiovascular outcomes, and hematology. She has served as the DMC member statistician on industry- and government-sponsored DMCs for randomized clinical trials and early feasibility studies and participates in NIH-sponsored protocol review committees.

Dr. Yu has spoken at professional meetings on the statistical challenges that arise in orphan disease trials and in small populations. At SCI, she also supervises biostatistical staff. Left to her own devices, she enjoys creating graphical displays of data in R and S+.

She received her B.A. in Mathematics and Philosophy from the University of Pennsylvania (1994) and her Sc.D. in Biostatistics from Harvard University (2002). Her dissertation was titled “Regression Methods for Quantitative Risk Assessment of Continuous Outcomes in Toxicology”.