Associate Director – Statistical Programming
🏢 Company: AstraZeneca (Alexion Division)
📍 Location: Bangalore, India
💼 Employment Type: Full-time
🆔 Job Requisition ID: R-236635
📅 Date Posted: 06-Oct-2025
📅 Closing Date: 12-Oct-2025
Role Overview
The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs. The role involves:
Supporting Biostatistics in statistical analysis and generating datasets, tables, listings, and figures.
Creating all files necessary for electronic submissions (eCTD format).
Managing direct line supervision of statistical programmers, optimizing staff utilization, and identifying training needs.
Overseeing external partners to ensure timely and quality deliverables.
Key Responsibilities
Leadership & Management
Serve as the Lead Programmer and Manager for statistical programming efforts.
Support the Clinical and Statistical Programming Director in team management and development.
Participate in process reviews to ensure compliance and continuous improvement.
Create/review programming plans and ensure proper resource allocation.
Act as the primary departmental contact for standard implementation.
Programming & Technical Expertise
Develop and validate technical programming specifications for analysis datasets (Alexion or ADaM standards).
Independently develop programs for analysis datasets, tables, listings, and figures/graphs.
Ensure proper study documentation filing compliant with audit standards.
Collaborate with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions for programming support.
Compliance & Documentation
Ensure adherence to company policies, SOPs, GCP, and 21CFR Part 11 standards.
Maintain compliance for all programming activities according to departmental standards.
Support integrated safety/efficacy analyses and eCTD submissions.
Essential Skills & Experience
10+ years in statistical programming (CRO or Pharmaceutical Industry).
4+ years of project management experience.
Experience with CDISC SDTM and ADaM standards.
Strong people management and supervisory skills.
Excellent verbal and written communication skills.
Advanced proficiency in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, SAS/SQL.
Knowledge of clinical database design (Inform, Medidata, Oracle).
Experience in:
Constructing technical programming specifications
Relational databases
Good Clinical Practices (GCP)
Good Programming Practices (GPP)
Integrated summary safety/efficacy analyses
eCTD electronic submissions
Desirable Skills & Education
BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related field.
Competencies:
Accountability, Collaboration, Decision Quality, Drive for Results
Perseverance, Problem Solving, Informing, Peer Relationships
Time Management, Building Effective Teams, Managing Through Systems
Company Overview & Culture
At Alexion, AstraZeneca’s division for rare diseases, we combine biotech agility with global biopharma resources. We foster inclusive innovation and empower employees to grow professionally and personally.
Equal Employment Opportunity
Alexion is an Equal Employment Opportunity and Affirmative Action Employer.
Employment decisions are not based on race, color, religion, sex, sexual orientation, age, disability, veteran status, gender identity, genetic information, or any other protected status.
Reasonable accommodations available: accommodations@Alexion.com
Participates in E-Verify.
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