Associate Director – Statistical Programming
Location: Bengaluru, India
Job Reference: R-243325
Experience Required: 7+ years in Statistical Programming; 4+ years in Project/Team Management
Date Posted: 12-Jan-2026
About the Role
Alexion, part of AstraZeneca Rare Disease Unit, is seeking an Associate Director – Statistical Programming to lead and oversee statistical programming activities across multiple clinical studies. This role is pivotal in maintaining high-quality programming deliverables, ensuring SOP compliance, and supporting Biostatistics in producing tables, listings, figures, and datasets for regulatory submissions, including eCTD filings.
The ideal candidate will have extensive SAS expertise, strong experience in CDISC SDTM/ADaM standards, and a proven track record in people management and cross-functional project leadership within the pharmaceutical or CRO environment.
Key Responsibilities
Leadership & Team Management
Lead, mentor, and supervise statistical programming teams, ensuring optimal staff utilization and development
Identify training needs and provide coaching for continuous skill enhancement
Oversee resource allocation, prioritization, and project assignments
Statistical Programming & Deliverables
Develop and validate technical programming specifications for analysis datasets (ADaM, SDTM) and protocol-specific efficacy tables, listings, figures, and graphs
Independently develop, test, and validate programs generating analysis datasets and outputs according to standards
Maintain study documentation in compliance with SOPs and audit-ready standards
Operational Excellence & Compliance
Support Clinical and Statistical Programming leadership in operational strategy and team development
Review, implement, and continuously improve statistical programming processes and procedures
Ensure adherence to company policies, SOPs, Good Clinical Practices (GCP), Good Programming Practices, and 21CFR Part 11 standards
Collaborate with Biostatistics, Clinical Data Management, Pharmacovigilance, and Clinical Operations to deliver high-quality programming outputs
Regulatory & Submission Support
Create all necessary files and outputs to support electronic submissions in eCTD format
Ensure integration with clinical database designs and EDC systems, including Inform, Medidata, and Oracle
Required Skills & Experience
7+ years of statistical programming experience in the pharmaceutical or CRO industry
4+ years project management or people management experience
Proficiency in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, SAS/SQL in Windows environments
Strong knowledge of CDISC SDTM and ADaM standards, transforming raw data into compliant datasets
Experience generating analysis datasets, tables, listings, figures, and graphs for clinical trials
Proven ability to manage cross-functional teams and projects from concept to completion
Excellent verbal and written communication skills
Understanding of clinical data processes, database design, and regulatory requirements
Desirable Skills
BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics, or related field
Experience with Integrated Summary of Safety/Efficacy Analyses
Competencies in team building, decision-making, problem-solving, accountability, collaboration, and time management
Familiarity with clinical trial submission standards, eCTD requirements, and Good Publication Practices
Why Join Alexion
Contribute to transformative therapies for rare disease patients worldwide
Work in an inclusive and collaborative culture that fosters innovation and professional growth
Be part of a global biopharma environment that combines biotech agility with AstraZeneca’s resources
Engage in meaningful work that directly impacts patient outcomes and regulatory success
Alexion is an Equal Employment Opportunity and Affirmative Action employer committed to fostering a culture of belonging. Reasonable accommodations are available for candidates as needed.
SEO Keywords:
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