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Associate Director - Statistical Programming

4-10 years
Not Disclosed
10 Oct. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.