PHARMAFull-time
Senior Statistical Programmer II
By Admin · Biostatistics & Statistical Programming
BANGALORE (IN)HYBRIDPOSTED: 8/29/2026
PHARMAFull-time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Statistical Programming & Analysis: Provide advanced statistical programming support and lead programming activities for clinical trial analysis, clinical study reports (CSRs), regulatory submissions, commercialization, and scientific utilization of data.
CDISC Standards Implementation: Develop and validate SDTM and ADaM datasets, as well as Tables, Figures, and Listings (TFLs) adhering strictly to CDISC standards and industry best practices.
Oncology Study Leadership: Lead statistical programming deliverables across assigned Oncology therapeutic area clinical studies, ensuring compliance with global regulatory standards and internal SOPs.
Regulatory Submissions Support: Prepare and review CDISC-compliant submission packages (including define.xml and reviewer guides) to support global regulatory interactions and submission filings.
Cross-Functional & Stakeholder Management: Collaborate effectively with global biostatistical, clinical operations, and data management teams, influencing project decisions and driving timely trial deliverables.
Technical & Domain Standards
Programming Languages & Platforms: Advanced SAS programming expertise (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro language).
Clinical Data Standards: CDISC (SDTM, ADaM), define.xml, regulatory submission standards (FDA, EMA).
Leadership & Career Scope
Study-Level Leadership: Act as a Subject Matter Expert (SME) and lead programmer on complex oncology trials, guiding junior team members and managing cross-functional stakeholder expectations.
Benefits & Work Culture
Work Setting: Hybrid work structure based out of Manyata Tech Park, Bangalore, offering robust career development, oncology drug pipeline exposure, and an inclusive work environment.
REQUIRED VERIFIED SKILLS
SAS Programming
CDISC
SDTM
ADaM
TFLs
Clinical Trial Submissions
Regulatory Compliance
Oncology Data Analysis
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
TEAM SIZE: 89,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare
RECOMMENDED TRAINING
1/5
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