Associate Director – Statistical Programming
🏢 Company: AstraZeneca (Alexion Division)
📍 Location: Bengaluru, India
🆔 Job Reference: R-236635
📅 Date Posted: 06 Oct 2025
⏰ Closing Date: 12 Oct 2025
💼 Employment Type: Full-time
Role Overview
The Associate Director of Statistical Programming will lead statistical programming activities across multiple clinical studies, ensuring high-quality, compliant, and timely deliverables. This role requires deep expertise in SAS programming, CDISC standards, and clinical data management, along with strong leadership and project management capabilities. The individual will oversee a team of programmers, manage external partners, and collaborate cross-functionally to support statistical analysis and regulatory submissions.
Key Responsibilities
Programming Leadership & Management
Serve as the Lead Programmer and Manager overseeing statistical programming efforts for multiple studies.
Provide direct line management to statistical programmers, ensuring effective supervision, training, and resource allocation.
Support the Clinical and Statistical Programming Director in managing team operations and strategic development.
Oversee day-to-day programming activities of external partners and vendors.
Programming & Data Analysis
Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
Independently design, develop, and validate programs that generate analysis datasets, tables, listings, and figures (TLFs).
Create files necessary to support electronic submissions (eCTD format).
Maintain accurate study documentation in compliance with SOPs and audit standards.
Process & Compliance
Ensure adherence to SOPs, company policies, GCP, and 21 CFR Part 11 standards.
Review and refine statistical programming processes for continuous improvement and regulatory compliance.
Act as the primary departmental contact to ensure consistent application of programming standards.
Cross-functional Collaboration
Work closely with Biostatistics, Clinical Data Management, Pharmacovigilance, and Clinical Operations to meet programming needs.
Provide programming support for integrated safety and efficacy analyses and cross-study data integration.
Essential Skills & Experience
10+ years of statistical programming experience in the CRO or pharmaceutical industry.
4+ years of project management experience in clinical or regulatory programming.
Expertise in CDISC SDTM and ADaM standards; ability to transform raw data into compliant formats.
Advanced proficiency in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL.
Proven experience developing, validating, and managing statistical programming deliverables.
Strong understanding of clinical database systems such as Inform, Medidata, or Oracle Clinical.
Solid grasp of Good Clinical Practice (GCP), Good Programming Practice (GPP), and regulatory submission standards.
Excellent communication, leadership, and supervisory skills.
Ability to lead cross-functional projects and manage multiple priorities.
Desirable Qualifications & Competencies
🎓 Education:
BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics, or related field.
🧠 Core Competencies:
Accountability
Collaboration
Decision Quality
Drive for Results
Problem Solving
Perseverance
Peer Relationships
Time Management
Building Effective Teams
Managing Through Systems
About Alexion (AstraZeneca Division)
At Alexion, we are driven by our mission to improve the lives of patients with rare diseases.
Combining the agility of a biotech with the global reach of AstraZeneca, we foster a culture of innovation, inclusion, and compassion — empowering our teams to make meaningful scientific and human impact.
Equal Employment Opportunity
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We are committed to a workplace where everyone belongs, regardless of:
race, color, religion, sex, sexual orientation, gender identity or expression, age, disability, veteran status, or other protected characteristics.
We also provide reasonable accommodations for candidates and employees with disabilities.
📩 For assistance, contact: accommodations@Alexion.com
Alexion participates in the E-Verify program.
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