About This Role
The Head of Biometrics serves as the senior technical authority for biostatistics and statistical programming, focusing on advancing methodologies across Phase II–IV clinical studies and real-world evidence studies. This role is ideal for an experienced leader who can engage with stakeholders and ensure high-quality scientific outputs.
Responsibilities
- Serve as the senior technical authority for biostatistics and statistical programming, applying and advancing fit-for-purpose methodologies across Phase II–IV clinical studies, including oncology, and real-world evidence studies.
- Provide strategic input into evidence-generation plans, study concepts, protocols, estimands, statistical analysis plans, data standards, programming specifications, and interpretation of results.
- Anticipate methodological, operational, and data-quality risks; propose pragmatic solutions; and lead project teams through implementation.
- Ensure analyses are scientifically rigorous, reproducible, compliant, and aligned with study objectives and internal quality standards.
- Translate complex statistical concepts, study designs, and findings into clear, decision-relevant insights for project teams, governance bodies, research institutions, and external stakeholders.
- Independently engage with senior and chief reviewers at China’s Center for Drug Evaluation (CDE) on study-design and statistical topics, building credible and constructive working relationships.
- Provide advanced statistical training, consultation, and interpretation to strengthen data literacy and evidence-based decision-making across functions.
- Represent the function in relevant internal and external scientific forums and contribute to the evolution of methodological standards and best practices.
- Set a compelling team vision aligned with company and China RWE & Data Science Centre priorities, and build an innovative, collaborative, academically strong, and delivery-focused organization.
- Establish and continuously improve governance, processes, templates, quality controls, resource planning, and vendor oversight for biostatistics and statistical programming deliverables.
- Prioritize the portfolio and allocate resources to deliver high-impact evidence-generation programmes on time and to quality.
- Partner effectively across therapeutic areas and with Clinical Operations, Epidemiology, RWE, Data Science, Medical Affairs, Regulatory, Market Access, and global evidence teams.
- Attract, develop, engage, and retain high-calibre statisticians and statistical programmers.
- Identify capability gaps and provide differentiated coaching, development plans, stretch assignments, and succession planning.
- Set clear objectives, hold team members accountable for outcomes and quality, and foster a culture of inclusion, continuous learning, and constructive challenge.
