Associate Director – Statistical Programming | Alexion, AstraZeneca Rare Disease Unit
Location: Bengaluru, India (Hybrid Work Model)
Job Reference: R-243325
Date Posted: 12-Jan-2026
Closing Date: 18-Jan-2026
Experience Required: 7+ years statistical programming, 4+ years project/people management
About Alexion, AstraZeneca Rare Disease
Alexion, part of AstraZeneca’s Rare Disease Unit, is a global biopharmaceutical company committed to transforming the lives of patients with severe and ultra-rare disorders. By combining the agility of biotech with the resources of a global pharma leader, Alexion drives innovation in rare disease treatments, focusing on life-changing therapies.
The company fosters an inclusive culture where innovation thrives, providing employees with opportunities for professional growth while maintaining a patient-centric focus.
Role Overview
The Associate Director – Statistical Programming will lead statistical programming operations across multiple clinical studies, managing both internal teams and external partners. This role ensures high-quality, timely deliverables while maintaining compliance with SOPs, CDISC standards, and regulatory guidelines.
This position requires extensive experience with SAS programming, clinical trial data standards, and regulatory submissions, combined with strong leadership, project management, and stakeholder collaboration skills.
Key Responsibilities
Leadership & Team Management:
Directly manage statistical programming teams, identifying training needs and optimizing resource utilization.
Provide supervision and mentorship to programmers, ensuring professional development and adherence to quality standards.
Statistical Programming Delivery:
Lead programming efforts for multiple clinical studies, including ADaM and SDTM datasets, efficacy tables, listings, and figures.
Develop, validate, and maintain technical programming specifications for analysis datasets and study deliverables.
Ensure accurate generation of outputs to support electronic submissions (eCTD).
Process Compliance & Quality:
Maintain programming infrastructure and documentation according to SOPs and audit standards.
Collaborate with Biostatistics, Clinical Data Management, Pharmacovigilance, and Clinical Operations to ensure programming needs are met.
Continuously review and improve statistical programming processes to optimize efficiency and quality.
Project & Resource Management:
Allocate resources effectively, prioritize tasks, and manage deliverables across multiple projects.
Oversee external partner activities to ensure adherence to project timelines and quality standards.
Act as the primary contact for departmental programming standards, policies, and governance.
Essential Skills & Experience
7+ years of statistical programming experience in pharmaceutical or CRO environments.
4+ years of project management or team leadership experience.
Proficient in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL; mastery of SAS procedures.
Strong experience in CDISC SDTM and ADaM standards, transforming raw clinical trial data into compliant datasets.
Expertise in technical programming specifications, tables/listings/figures, and eCTD submissions.
Knowledge of clinical database design and electronic data capture systems (Medidata, Inform, Oracle).
Strong verbal and written communication skills for cross-functional collaboration and stakeholder engagement.
In-depth understanding of Good Clinical Practices (GCP), Good Programming Practices, and 21CFR Part 11 standards.
Preferred Qualifications & Skills
BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics, or related field.
Proven ability to lead cross-functional projects and teams, manage priorities, and deliver under tight deadlines.
Competencies: Accountability, Collaboration, Decision Quality, Problem Solving, Time Management, Building Effective Teams.
Why Join Alexion?
Hybrid Work Environment: Flexible in-office schedule for enhanced collaboration and productivity.
Global Impact: Contribute to life-changing therapies for rare disease patients worldwide.
Career Growth: Leadership role with exposure to clinical programming operations, strategic decision-making, and cross-functional collaboration.
Inclusive Culture: Thrive in a workplace where diversity and innovation are valued and celebrated.
Alexion is an Equal Opportunity Employer and provides reasonable accommodations to support candidates with disabilities.
Apply Now: Join Alexion to lead statistical programming initiatives that support innovative rare disease therapies and make a measurable impact on patient outcomes.
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