Statistical Programming Associate Director
Location: Bangalore, India
Job Type: Full-Time
Job Requisition ID: R-245613
Application Deadline: 29 April 2026
Company Overview
AstraZeneca is a global, science-led biopharmaceutical organization committed to transforming patient outcomes through innovative research and data-driven clinical development. With a strong focus on oncology, AstraZeneca continues to advance a robust pipeline across multiple indications aimed at eliminating cancer as a cause of death.
Role Overview
The Statistical Programming Associate Director is a senior leadership position within the Oncology Biometrics Programming function. This role is responsible for leading statistical programming strategy and execution at the project and study level, ensuring high-quality delivery of programming outputs that support clinical study reports, regulatory submissions, and commercialization activities.
The position plays a critical role in enabling evidence-based decision-making across clinical development programs and regulatory interactions. The successful candidate will collaborate closely with biostatistics, clinical development, regulatory, and data management teams to ensure timely, compliant, and scientifically robust deliverables.
Key Responsibilities
Statistical Programming Leadership
Lead statistical programming activities across assigned oncology clinical studies and projects.
Oversee planning, execution, validation, and delivery of programming outputs aligned with regulatory standards.
Ensure high-quality production of datasets, tables, listings, and figures (TLFs) for clinical study reports and global submissions.
Drive programming strategy for submissions to regulatory authorities including FDA, EMA, and other global agencies.
Regulatory & Standards Compliance
Ensure compliance with CDISC standards including SDTM and ADaM.
Maintain adherence to internal SOPs and global regulatory requirements.
Support audit readiness and inspection activities as required.
Project & Team Management
Provide leadership and oversight to statistical programmers at study or project level.
Manage timelines, resources, and quality control across concurrent programs.
Collaborate cross-functionally with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs.
Influence stakeholders through strong technical expertise and strategic input.
Scientific & Commercial Support
Contribute to data analysis strategies supporting commercialization and lifecycle management.
Enable scientific utilization of clinical data to support publications and strategic decision-making.
Experience Required
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
Minimum 10–14 years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO industry.
Advanced SAS programming expertise in clinical drug development.
Extensive hands-on experience in oncology clinical trials preferred.
Proven experience leading studies or large-scale regulatory submissions.
Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory guidelines (FDA, EMA, ICH).
Demonstrated ability to manage multiple concurrent projects with high attention to detail.
Excellent verbal and written communication skills with stakeholder management capability.
Preferred Qualifications
Experience supporting global NDA/BLA/MAA submissions.
Prior leadership experience in a matrix global environment.
Exposure to advanced analytics or programming automation initiatives.
Work Model
Hybrid work model based in Bangalore with an expectation of working from the office at least three days per week, offering flexibility aligned with business needs.
Why Join AstraZeneca?
Opportunity to lead statistical programming strategy in a high-impact oncology pipeline.
Exposure to global regulatory submissions and advanced clinical development programs.
Collaborative environment driven by science, innovation, and data excellence.
Clear leadership pathway within global biometrics and clinical development functions.
SEO & GEO Keywords: Statistical Programming Associate Director Jobs Bangalore, Oncology Statistical Programming India, SAS Programming Leadership Roles Bangalore, CDISC SDTM ADaM Jobs India, Pharmaceutical Biometrics Careers Bangalore, Regulatory Submission Programming Jobs India, AstraZeneca Oncology Careers.
This senior-level opportunity is ideal for experienced statistical programming leaders seeking oncology-focused biometrics roles in Bangalore within a globally recognized pharmaceutical organization.
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