Senior Statistical Programmer
ROLE OVERVIEW
This Senior Statistical Programmer II role sits within AstraZeneca's Oncology Biometrics Programming department, a critical function that turns complex clinical trial data into regulatory-ready evidence. Reporting to a programming leader, you will support and lead statistical programming activities across high-priority oncology studies, from clinical study reports to health authority submissions and commercialisation support. The position is central to AstraZeneca's ambition to eliminate cancer as a cause of death, as every analysis dataset and TLF contributes to faster filings and informed decisions. For experienced SAS programmers, this is a compelling opportunity to work on a rich oncology pipeline, influence submission strategies, and collaborate with global biostatisticians, clinicians, and regulatory experts. Based in Bangalore with hybrid flexibility, the role offers visibility, technical depth, and a clear path to principal-level programming leadership.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead and deliver statistical programming activities for oncology clinical trials, including analysis datasets, tables, listings, figures, and patient profiles.
- •Develop, validate, and maintain advanced SAS programs for clinical study reports, regulatory submissions, and ad-hoc exploratory analyses.
- •Implement CDISC standards, including SDTM and ADaM, ensuring all deliverables are submission-ready and inspection-compliant.
- •Collaborate with biostatisticians, clinical data managers, medical writers, and regulatory colleagues to define and meet analysis timelines.
- •Provide programming leadership on concurrent studies, manage stakeholder expectations, and mentor junior programmers as needed.
- •Support health authority responses, submission packages, and post-marketing commitments with accurate, auditable programming evidence.
- •Drive process improvements, reusable macros, and best practices to increase efficiency and quality across the programming group.
- •Maintain comprehensive documentation and version control in line with ICH-GCP, 21 CFR Part 11, and AstraZeneca SOPs.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's or Master's degree in Mathematics, Statistics, Computer Science, Life Sciences, Social Sciences, or a related discipline.
- At least 5 years of industry statistical programming experience with a Bachelor's, or 3 years with a Master's degree.
- Advanced SAS programming expertise within clinical drug development, including macro development and debugging.
- Strong knowledge of CDISC standards, regulatory requirements, and submission processes.
- Proven experience leading studies or programming activities in oncology clinical trials.
- Demonstrated stakeholder management and ability to work with global cross-functional teams.
- Excellent verbal and written communication skills, with attention to detail and multitasking ability.
PREFERRED QUALIFICATIONS
- •R or Python for statistical programming
- •Experience across multiple therapeutic areas
- •Mentoring or coaching junior programmers
- •Process automation and macro library development
- •Global submission experience across regions
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
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