Associate Director – Statistical Science (Biostatistics)
ROLE OVERVIEW
AstraZeneca's Statistical Science Associate Director role sits at the heart of the company's evidence-generation engine, shaping how pivotal trials in oncology and other therapeutic areas are designed, simulated and interpreted. Based in Bengaluru and operating on a hybrid model, this individual-contributor position carries genuine decision-making weight: the statistics you deliver directly inform go/no-go calls on multi-million-dollar development programmes. Because AstraZeneca runs one of the industry's most ambitious oncology pipelines, the role offers exposure to complex adaptive designs, event-driven analyses and regulatory-grade submissions across global markets. It is a compelling opportunity for a senior biostatistician who wants to move beyond single-study delivery into portfolio-level influence, mentoring talent, directing CRO partners and applying novel statistical methodology. The position blends scientific rigour with visible strategic impact, making it a strong platform for progression toward Global Statistical Science Director or Biometrics leadership.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead statistical design, analysis and interpretation for one or more Phase II/III studies or an indication within a complex project, acting as study statistician of record.
- •Build and evaluate study design options, including adaptive, group-sequential and Bayesian approaches, and present trade-offs to governance teams.
- •Conduct statistical modelling and simulation, such as event-driven timing and predictive probability of success, to forecast interim and final analysis readouts.
- •Direct internal statistical staff and CRO biometrics partners, reviewing deliverables for quality, timeline adherence and SOP compliance.
- •Author and review statistical analysis plans, TLF shells, randomisation specifications and statistical sections of protocols, CSRs and regulatory submissions.
- •Provide high-quality decision support to clinical and development leadership, translating statistical uncertainty into clear risk-benefit recommendations.
- •Investigate and implement novel statistical methodology aligned with regulatory guidance, including ICH E9/E9(R1) and FDA/EMA oncology endpoints.
- •Mentor junior statisticians and contribute to internal training, standards and process improvement initiatives.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- MSc or PhD in Statistics, Biostatistics, or a recognised equivalent quantitative discipline.
- Minimum 5+ years of pharmaceutical or biotech development experience covering data analysis and interpretation.
- Demonstrated experience in programme design and execution, ideally designing and running a Phase III oncology study.
- Strong hands-on programming ability in R and/or SAS for analysis and simulation work.
- Proven track record leading biometrics delivery, including oversight of CRO partners.
- Working knowledge of technical and regulatory requirements such as ICH-GCP and ICH E9(R1) governing clinical statistics.
- Excellent communication skills with the ability to build strong relationships across functional boundaries.
PREFERRED QUALIFICATIONS
- •Bayesian Modelling & MCMC Simulation
- •Real-World Evidence and External Control Arm Methods
- •Machine Learning for Biomarker Subgroup Analysis
- •Multi-Therapeutic-Area or Global Team Experience
- •Define.xml and Electronic Submission Package Preparation
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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