Hui Liu
Sr Manager, Biostatistics @Alexion Pharmaceuticals, Inc.
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WORK HISTORY
Sr Manager, Biostatistics @Alexion Pharmaceuticals, Inc.
Boston, MA, US
Contribute to the statistical leadership to high-stakes NHS, Phase 2 & 3 pivotal trials, managing end-to-end statistical operations and ensuring data readiness for global regulatory submissions- Pioneered interactive data visualization initiatives and conducted simulation-based approach to stress-test primary endpoint assumptions, mitigating risk for a multi-billion dollar cardiovascular program- Directly authored Statistical Analysis Plans (SAPs) and responded to complex regulatory inquiries from the FDA and EMA.
EDUCATION
Rutgers University
Ph.D., Environmental Sciences
Rutgers, The State University of New Jersey-New Brunswick
M.S., Statistics
SKILLS
ABOUT HUI LIU
Bridging the gap between complex biological mechanisms and rigorous statistical evidence. With a Ph.D. in the Life Sciences and an M.S. in Statistics, I offer a unique ‘Scientist-Statistician’ perspective that transforms data into decisive R&D strategy in clinical trials, process development, and routine monitoring. Over the past 13+ years, I have applied advanced quantitative methods to solve the industry’s most complex challenges across RNAi, Gene Therapy, and Rare Disease. My expertise spans the full drug lifecycle—from pioneering CMC statistical frameworks to Phase 3 clinical strategy and regulatory submissions (FDA, EMA, PMDA). I am a high-engagement leader dedicated to driving innovation, automating workflows, and accelerating the delivery of transformative medicines to patients.I specialize in- Clinical Leadership: End-to-end trial ownership (Phase 1-3), protocol design, estimands, and SAP development- Regulatory Success: Proven track record with FDA, EMA, CFDA, and PMDA submissions and direct query resolution- Innovation: Reducing analysis cycle times by 50% through advanced R-based automation and interactive visual analytics- Strategic Influence: Bridging the gap between Statistics, Clinical Ops, and CMC to accelerate decision-making in rare disease and cardiovascular pipelines.
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