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Senior Statistician Ii

Astrazeneca
AstraZeneca
6-10 years
Not Disclosed
Bangalore, India
10 March 3, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Statistician II

Location: Bangalore, India
Job Type: Full-Time
Job Requisition ID: R-245142
Application Deadline: 30 March 2026

Company Overview
AstraZeneca is a global, science-led biopharmaceutical organization focused on advancing innovative medicines across oncology and other serious diseases. With a strong emphasis on data science, modelling, and regulatory excellence, AstraZeneca integrates advanced statistical methodologies into every stage of drug development to accelerate patient access to life-changing therapies.

Role Overview
The Senior Statistician II is a high-impact leadership role within global clinical development, responsible for providing advanced statistical expertise across complex clinical programs. This position supports study design, modelling and simulation, regulatory submissions, and strategic decision-making at enterprise level.

The role offers strong visibility across governance committees and regulatory interactions, making it ideal for experienced statisticians seeking senior biostatistics jobs in Bangalore within a global pharmaceutical environment.

Key Responsibilities

Advanced Statistical Design & Program Leadership

  • Provide statistical expertise for complex preclinical and clinical development programs.

  • Support high-level internal governance committees and regulatory submission strategies.

  • Advise on commercialization decisions through evidence-based statistical insights.

Modelling & Simulation

  • Analyse internal and external datasets to inform study design and decision criteria.

  • Conduct modelling and simulation to accelerate program progression and reduce development risk.

  • Identify opportunities to improve methodology and implement innovative statistical techniques.

Statistical Analysis Planning

  • Develop and author Statistical Analysis Plans (SAPs) for complex clinical studies.

  • Ensure reproducibility, compliance, and alignment with regulatory standards.

  • Oversee quality and integrity of statistical outputs and deliverables.

Results Interpretation & Regulatory Contributions

  • Analyse, interpret, and communicate results of complex studies to cross-functional stakeholders.

  • Contribute to regulatory submissions, including overview documents and responses to regulatory queries.

  • Translate statistical findings into clear, compliant narratives for global health authorities (FDA, EMA, ICH).

Coaching & Methodology Development

  • Mentor and guide junior statisticians, elevating quality and consistency standards.

  • Contribute to development of standard processes to improve efficiency and scalability.

  • Engage with external scientific communities and academic collaborators to implement innovative methodologies.

  • Participate in conferences and publications to share research insights.

Experience Required

  • Master’s or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.

  • Minimum 6–10 years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry.

  • Demonstrated expertise in complex clinical trial design and advanced statistical methodologies.

  • Strong experience in modelling and simulation within clinical development.

  • Proven involvement in regulatory submissions and health authority interactions.

  • Experience drafting and reviewing Statistical Analysis Plans for late-phase studies.

  • Ability to independently manage deliverables and provide strategic statistical guidance.

  • Strong communication skills with the ability to influence cross-functional and senior stakeholders.

Preferred Qualifications

  • Experience supporting global NDA, BLA, or MAA submissions.

  • Exposure to oncology or other complex therapeutic areas.

  • Publication record or conference participation in statistical research.

  • Experience contributing to process improvement or capability-building initiatives.

Work Model
Hybrid role based in Bangalore with an expectation of working from the office at least three days per week, supporting collaborative program execution while maintaining flexibility.

Why Join AstraZeneca?

  • Opportunity to influence pivotal decisions in global drug development programs.

  • Exposure to advanced modelling, simulation, and regulatory strategy.

  • High visibility role with leadership impact across clinical and governance functions.

  • Career progression within global biostatistics and clinical development teams.

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This opportunity is suited for experienced biostatisticians seeking senior-level clinical statistics roles in Bangalore within a globally recognized pharmaceutical organization focused on scientific excellence and regulatory innovation.