Chair, General Chapters–Statistics Expert Committee
Career Highlights:
- Pfizer Research & Development: Executive Director Biostatistics, Senior Director Biostatistics, Director Biostatistics Merck Research Laboratories: Associate Director Statistics, Senior Biometrician, Biometritian, Senior Project Statistician
Education:
- Temple University, Ph.D., Statistics
- Fudan University, B.S., Applied Mathematics
Awards, Recognition, Admissions:
- W.J. Youden Award in Interlaboratory Testing from the American Statistical Association
- Chair of Advisory Committee on Continuing Education for the American Statistical Association
- President of Philadelphia Chapter of the American Statistical Association
A Few Favorite Professional Achievements:
- USP Statistics Expert Committee: member since 2003
- Provided statistical support for various vaccine programs and small molecule programs, including product release and quality.
- Led the statistical support for the lightspeed delivery of COVID mRNA vaccine on preclinical development and clinical assay validation.
- Led the statistical support for the Paxlovid program, as well as other antiviral programs, for assay validation and development ranging from vaccine clinical and diagnostic assays to anti-drug antibody (ADA) assays, to biomarker assays in preclinical development.
- Developed an innovative algorithm that emphasizes practical context for determination of cut points for ADA assays and championed its wider use among regulators and industrial peers.
