Jeen (Jing-Ou) Liu
Council Member
Jeen Liu is Vice President, Biostatistics and Data
Management at Regeneron, where he leads Biostatistics,
Statistical Programming, and Clinical Data Management
supporting clinical development from Phase I through Phase
IV. With more than two decades of experience spanning
Novartis, Astellas, Eisai, Allergan, and Regeneron, he has
built a career defining biostatistics leadership across the
pharmaceutical industry.
Dr. Liu has led biostatistics strategy for major regulatory
submissions across therapeutic areas including
immunology/allergic asthma (Xolair), gastroenterology
(Zelnorm), ophthalmology, neurotoxin/CNS, and oncology,
contributing to more than 20 BLA, NDA, MAA, and IND
approvals and representing his companies in four FDA
advisory committee meetings. He is known for pairing
rigorous statistical science with regulatory strategy — from
designing the adaptive, sample-size re-estimation approach
that persuaded the FDA to reduce sample size in the Phase 3
ARTEMIS 2 glaucoma program, to redefining the primary
endpoint for asthma trials around exacerbation reduction as
lead statistician for Xolair.
He also has a strong record of organizational building —
growing departments, establishing standards and governance,
and cultivating statistical talent through fellowships,
internships, and programs like BRIDGE. He is active in the
biostatistics professional community, with leadership roles
in the ASA Biopharmaceutical Section Regulatory-Industry
Statistics Workshop and the International Chinese
Statistician Association, and has authored numerous
peer-reviewed publications and R packages on clinical trial
design.
Dr. Liu holds a Ph.D. in Statistics from UC Berkeley and a
Bachelor's in Applied Mathematics from the University of
Science and Technology of China.
