Senior Biostatistician II
By Admin · Biostatistics & Statistical Programming
ROLE OVERVIEW
At AstraZeneca, the Senior Statistician II role sits within the Biometrics and Statistical Innovation function, supporting late-phase oncology trials and regulatory submissions. This position is central to translating complex clinical questions into rigorous statistical designs, ensuring every protocol, analysis and dataset can withstand health authority scrutiny. The statistician partners with clinicians, translational scientists and data experts to generate reliable evidence across a rich pipeline of high-quality molecules and multiple indications. Because oncology trials often rely on time-to-event endpoints, this role directly influences how survival benefits are measured and communicated. It is a compelling opportunity for an experienced biostatistician to work at the intersection of modern science and advanced analytics, with strong investment in methods innovation, global academic collaborations and a culture that values curiosity, collaboration and smart risk-taking. Hybrid working in Bangalore adds flexibility.
ROLE DEFINITION & RESPONSIBILITIES
- •Provide expert statistical input into clinical trial protocols, endpoint definitions, sample size assumptions, randomization strategies and analysis populations for oncology studies.
- •Design, conduct and interpret complex statistical analyses, including survival analysis, longitudinal modeling, categorical data analysis and subgroup evaluations using SAS and R.
- •Review and validate statistical analysis plans, derived datasets, tables, figures and listings, ensuring deliverables meet AstraZeneca standards and regulatory submission requirements.
- •Translate scientific questions into appropriate statistical approaches, collaborating closely with clinicians, statistical programmers, data managers and translational scientists.
- •Maintain meticulous documentation of statistical methods, analysis decisions and outputs to support transparency, reproducibility and health authority submissions.
- •Monitor compliance with ICH-GCP, internal SOPs and regulatory guidance, promptly escalating any non-compliant processes or quality issues.
- •Contribute to biostatistics best practices, mentor junior statisticians and engage with internal and external statistical communities to advance methods.
- •Support regulatory interactions and responses by providing clear statistical summaries, justifications and sensitivity analyses for health authority questions.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master’s degree in Statistics, Biostatistics or a closely related quantitative discipline is required; a PhD is strongly preferred.
- Minimum of 6–10 years of biostatistical experience in clinical research, preferably within the pharmaceutical, biotechnology or CRO environment.
- Proven experience supporting oncology clinical trials, including survival analysis, time-to-event endpoints and interim analyses.
- Strong working knowledge of ICH-GCP, regulatory statistical guidelines and clinical trial reporting standards.
- Hands-on proficiency with SAS and R for statistical programming, data manipulation and reproducible analysis.
- Experience contributing to statistical analysis plans, protocol development, CSR contributions and regulatory submission packages.
PREFERRED QUALIFICATIONS
- •PhD in Statistics or Biostatistics
- •CDISC SDTM/ADaM Implementation
- •Bayesian Statistical Methods
- •Real-World Evidence (RWE)
- •Health Authority Interaction Experience
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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