Tsz Keung (Ken) Nip
Executive Director, Head of Biometrics @ MediLink Therapeutics
About
An experienced international biostatistics leader with over 25 years of experience across the U.K., U.S., and China. Currently Head of Biometrics, overseeing statistics, programming, and data management, with expertise in clinical trial design and regulatory submissions (BLA/NDA, MAA, and supplemental filings). Proven track record supporting regulatory approvals, including Adbelimab, Pyrotinib, and Camrelizumab, and committed to advancing best practices in clinical trial design and statistical methodology.
China
Shanghai
Pharmaceuticals
SAS, Biostatistics, Clinical Development, Clinical Trials, Protocol, Survival Analysis, Statistical Modeling, SAS programming, EDC, Oracle Clinical, Outcomes Research, Data Management, Clinical Data Management, GCP, CTMS, Pharmaceutical Industry, CDISC, Regulatory Submissions, Statistics, Mixed Model
Experience
Executive Director, Head of Biometrics
MediLink Therapeutics
Senior Director/Director/Associate Director of Biostatistics, Group Lead
Hengrui Pharma
Shanghai, China
Senior Principal Statistician
Takeda
London, United Kingdom
Principal Statistician
Takeda
London, United Kingdom
Project Statistician
Takeda
London, United Kingdom
Project Statistician
Takeda
Chicago, USA
Senior Statistician
Takeda
London, United Kingdom
Research Statistician
Oxford GlycoSciences (UK) Limited
Oxford, United Kingdom
Biostatistician
Pharmaceutical Research Associates, Inc.
Reading, United Kingdom
Statistician
BRITISH BIOTECH (UK) LIMITED
Oxford, United Kingdom
Education
University of Reading
Biometry/Biometrics
University of Surrey
Mathematics and Statistics
Tsz Keung (Ken) Nip's Contact Information
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