Statistics Collaborative - Design and analysis for biomedical research

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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 study statistician supporting clinical trials run at academic research centers and small biotechnology companies. She has written and contributed to statistical analysis plans for Phase 2 and 3 treatment trials in oncology, inborn errors of metabolism, malaria, menopause, ophthalmology, and cardiovascular outcomes. She has analyzed clinical trial data from longitudinal studies in these areas, as well as pre-clinical data from animal studies and observational data in malaria and hematology. 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, development of analysis plans, and other statistical issues to SCI’s clients.

Dr. Yu has experience with the statistical and regulatory issues involved in evaluations of drugs, devices, gene therapy, and replacement enzyme interventions. She was the statistical lead for BLA preparations for orphan indication trials of treatments for MPS-VI and for inherited retinal diseases caused by mutations in the RPE65 gene, leading the final statistical analyses, coordinating the statistical aspects of Clinical Study Reports (CSR), and interacting with the FDA and EMA. She also supported a Pre-Market Approval (PMA) application for a device to treat thoracic aortic aneurysms, drafting the CSR statistical sections and PMA final briefing documents and preparing additional analysis for mock and actual FDA advisory panel meetings.

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, and hematology. She has also served as the DMC member statistician on industry- and government-sponsored DMCs for randomized clinical trials in asthma, colorectal cancer, pancreatic cancer, liver disease, lupus, inborn errors of metabolism, and communications disorders, as well as feasibility studies investigating endovascular devices.

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”. Previously she was a faculty member at St. George’s School in Newport, Rhode Island (1994-1996).