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Leading the biostatistics and statistical programming function across Phase II
–IV clinical studies and real-world evidence studies is the core of this role.
This position requires strong statistical leadership, scientific expertise, and
operational leadership, with a focus on advancing methodologies and ensuring
rigorous, reproducible analyses. The role suits a leader who can build an
innovative, collaborative, and delivery-focused team while engaging with
external stakeholders and providing strategic input into evidence-generation
plans.
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
Review and approve key team deliverables to ensure scientific quality,
compliance, and consistency with internal standards and processes
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
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
Nice to have:
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
AstraZeneca embraces diversity and equality of opportunity. They 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.
Headquarters
China
Open jobs
1618
Website
astrazeneca.com