ROLE & RESPONSIBILITIES
Statistical Leadership & Scientific Expertise
- 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.
Scientific Communication, Consulting & External Engagement
- 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.
Functional & Operational Leadership
- 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.
People Leadership
- 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.
- Review and approve key team deliverables to ensure scientific quality, compliance, and consistency with internal standards and processes.
REQUIREMENTS
Education & Experience
- Master’s degree or PhD in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline; PhD preferred.
- At least 8 years of relevant experience in biostatistics and/or statistical programming within the pharmaceutical, biotechnology, CRO, academic, or healthcare research setting.
- Demonstrated experience leading complex clinical-development or real-world evidence programmes and providing strategic statistical input across multiple stakeholders.
Technical & Professional Capabilities
- Proven ability to develop and review statistical strategies, study designs, statistical analysis plans, programming deliverables, analysis methods, and statistical reports for large, high-priority Phase II–IV clinical or external-sponsored research programmes, including programmes with investments exceeding RMB 10 million.
- Strong command of clinical-trial and observational-study methodologies, including appropriate approaches to bias, confounding, missing data, multiplicity, sensitivity analyses, and causal interpretation.
- Working knowledge of relevant regulatory expectations, data standards, quality requirements, and good clinical and pharmacoepidemiology practices.
- Ability to independently communicate with senior CDE reviewers on study design and statistical issues and to provide strategic consultation and coaching to team members and cross-functional colleagues.
- Excellent written and verbal communication skills, with the ability to influence senior stakeholders and build trusted relationships internally and externally.
- Demonstrated collaboration across global, regional, and local teams and across functional boundaries.
- Strong problem-solving, judgement, quality focus, and accountability for statistical and programming deliverables.
- Proven leadership skills, including the ability to direct multiple workstreams, manage priorities, and deliver through others.
Preferred Qualifications
- Formal people-management experience, including talent development and performance management.
- Experience with both clinical trials and real-world evidence, including work across more than one therapeutic area; oncology experience is an advantage.
- Experience managing statistical programming capabilities, external vendors, or service providers.
- Broad understanding of Medical Affairs, evidence generation, regulatory, access, and publication activities.
Date Posted
01-9月-2026
Closing Date
30-12月-2026
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.