Head of Biometrics

About the role

AstraZeneca is looking for a Head of Biometrics to act as the senior technical authority for biostatistics and statistical programming in China. The role applies and advances fit-for-purpose methodologies across Phase II-IV clinical studies, including oncology, and real-world evidence (RWE) studies, and leads the function's strategy, governance, team and external engagement.

Key responsibilities

• Lead biostatistics and statistical programming, covering study concepts, protocols, estimands, statistical analysis plans, data standards, programming specifications and result interpretation
• Anticipate methodological, operational and data-quality risks and lead project teams through implementation
• Ensure analyses are scientifically rigorous, reproducible, compliant and aligned with study objectives and quality standards
• Engage independently with senior and chief reviewers at China's Center for Drug Evaluation (CDE) on study design and statistics, and provide advanced statistical training and consultation
• Represent the function in internal and external scientific forums and help evolve methodological standards
• Build an innovative, collaborative team, set up governance, processes, quality controls, resource planning and vendor oversight, and partner with Clinical Operations, Epidemiology, RWE, Data Science, Medical Affairs, Regulatory and Market Access
• Recruit, coach and develop statisticians and statistical programmers, approve key deliverables and plan succession

Required profile

• Master's degree or PhD in Statistics, Biostatistics, Mathematics, Data Science or a related quantitative discipline (PhD preferred)
• At least 8 years of experience in biostatistics and/or statistical programming in pharma, biotech, CRO, academic or healthcare research settings
• Experience leading complex clinical-development or RWE programmes and giving strategic statistical input to multiple stakeholders
• Preferred: formal people-management experience, experience with both clinical trials and RWE across more than one therapeutic area (oncology is an advantage), and experience managing statistical programming capabilities, vendors or service providers

Required skills

• Develop and review statistical strategies, study designs, analysis plans, programming deliverables, methods and reports for large Phase II-IV or external-sponsored programmes
• Strong command of clinical-trial and observational-study methodology, including bias, confounding, missing data, multiplicity, sensitivity analyses and causal interpretation
• Working knowledge of regulatory expectations, data standards, quality requirements and good clinical and pharmacoepidemiology practices
• Ability to communicate with senior CDE reviewers and influence senior stakeholders
• Leadership skills: directing multiple workstreams, managing priorities and delivering through others