Associate Director, Statistical Programming – Oncology Biometrics
ROLE OVERVIEW
The Statistical Programming Associate Director role within AstraZeneca's Oncology Biometrics unit in Bangalore is a senior leadership position at the intersection of clinical data science and regulatory strategy. Reporting to the Director of Statistical Programming, the position owns the planning, execution and delivery of statistical programming activities at project and study level — from clinical study report development to pivotal regulatory submissions and commercialisation support. Because AstraZeneca's ambition to eliminate cancer as a cause of death depends on converting complex trial data into credible, submission-ready evidence, this role directly influences filing timelines and approval outcomes. For an experienced SAS and CDISC leader, it offers rare exposure to global filings, cross-functional influence and a genuinely patient-centred scientific mission.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead statistical programming delivery for oncology studies, from database lock through analysis datasets, TFLs and clinical study report finalisation.
- •Translate statistical analysis plans into robust, auditable SAS programs with full traceability and reproducibility.
- •Author and maintain SDTM and ADaM specifications, define.xml and reviewer's guides supporting integrated and pooled analyses.
- •Plan programming support for FDA, EMA and PMDA submissions, including electronic packages and health-authority query responses.
- •Manage, mentor and resource a distributed programmer team, reviewing deliverables and building technical capability.
- •Partner with statisticians, data managers, medical writers and regulatory colleagues to align timelines and mitigate risk.
- •Drive automation through SAS macros and open-source R tooling to shorten cycle times and raise quality.
- •Represent programming in governance forums, audits and regulatory inspections.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's or Master's degree in Mathematics, Statistics, Computer Science, Life Sciences or a related discipline.
- Minimum 10 years of industry statistical programming experience within clinical drug development, ideally in oncology.
- Proven experience leading programming activities at project or study level, including submission-facing deliverables.
- Advanced SAS programming expertise; working knowledge of R or equivalent open-source statistical tools.
- Comprehensive understanding of CDISC (SDTM/ADaM) standards and ICH-GCP regulatory requirements.
- Demonstrated ability to manage concurrent projects, competing priorities and global cross-functional stakeholders.
- Strong written and verbal communication skills with the credibility to influence senior decision-makers.
PREFERRED QUALIFICATIONS
- •Prior FDA BIMO or EMA submission lifecycle experience
- •Health authority audit and inspection readiness exposure
- •Automation using R Shiny, Python or SAS macros
- •Cloud SAS environments and Git version control
- •Oncology biomarker or immuno-oncology data 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
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.