Job Title: Associate Director – Statistical Programming
Job Reference: R-243325
Location: Bengaluru, India
Employment Type: Full-Time
Date Posted: 19 January 2026
Application Closing Date: 25 January 2026
Alexion, the rare disease division of AstraZeneca, is seeking an accomplished Associate Director – Statistical Programming to lead and oversee statistical programming activities across multiple clinical studies. This senior leadership role is based in Bengaluru, India, and plays a critical part in supporting biostatistics, clinical development, and regulatory submissions through high-quality, compliant, and timely programming deliverables.
The role requires deep expertise in SAS programming, CDISC standards (SDTM/ADaM), electronic submissions (eCTD), and strong people and vendor management capabilities. The successful candidate will drive programming strategy, ensure adherence to SOPs and regulatory standards, and mentor high-performing statistical programming teams.
Serve as Lead Programmer and provide strategic oversight for statistical programming across multiple clinical trials.
Develop, review, and validate technical programming specifications for analysis datasets using ADaM/Alexion standards.
Independently develop and validate SAS programs for analysis datasets, tables, listings, and figures (TLFs).
Ensure high-quality, audit-ready study documentation and programming deliverables.
Support biostatistics in statistical analyses and generate all programming outputs required for eCTD regulatory submissions.
Ensure compliance with Good Clinical Practices (GCP), Good Programming Practices, and 21 CFR Part 11 requirements.
Contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses.
Provide direct line management, mentoring, and performance oversight to statistical programmers.
Identify training needs, optimize resource utilization, and build high-performing programming teams.
Manage day-to-day activities and deliverables of external programming partners and vendors.
Act as the primary statistical programming contact to ensure consistent implementation of departmental standards across studies.
Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other internal stakeholders.
Lead continuous improvement initiatives to enhance programming processes, efficiency, and quality.
Experience Required:
7+ years of experience in statistical programming within a CRO or pharmaceutical/biopharmaceutical environment.
4+ years of project and people management experience in statistical programming or related functions.
Technical Expertise:
Advanced proficiency in SAS/Base, SAS/Macro, SAS/STAT, SAS/GRAPH, and SAS/SQL.
Strong experience with CDISC SDTM and ADaM standards, including transformation of raw clinical data.
Proven expertise in developing and validating analysis datasets, TLFs, and submission-ready outputs.
Experience with clinical databases and EDC systems such as Medidata, Inform, and Oracle.
In-depth knowledge of eCTD submissions, relational databases, and regulatory compliance standards.
Leadership & Communication:
Demonstrated people leadership and supervisory experience with strong mentoring capabilities.
Excellent written and verbal communication skills with the ability to influence cross-functional teams.
Strong understanding of biostatistics, clinical data management, and pharmacovigilance workflows.
Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related discipline.
Associate Director Statistical Programming, SAS Programming Jobs India, CDISC SDTM ADaM, Clinical Trial Programming, eCTD Submissions, Statistical Programming Leadership, Biostatistics Support, Pharma Programming Careers, Regulatory Submissions Programming, CRO Statistical Programming.
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