Senior Statistical Programming Specialist
Location: Bangalore, India (Hybrid / Remote options may apply)
Employment Type: Full-Time
Job ID: 261989
Job Overview
The Senior Statistical Programming Specialist is responsible for leading statistical programming activities for clinical studies (primarily CP studies). This role involves end-to-end oversight of programming deliverables, ensuring high-quality outputs, compliance with CDISC standards, and timely delivery within budget and project constraints.
The role may function as a Lead Statistical Programmer with guidance from senior programming staff and plays a key part in ensuring accuracy and integrity of clinical trial analysis data.
Key Responsibilities
Study Programming Leadership
Lead and oversee all statistical programming activities for assigned studies
Plan and manage programming timelines, resource allocation, and budgets
Ensure high-quality delivery of outputs while meeting study milestones
Coordinate with internal teams and clients to align expectations and deliverables
SAS Programming & Data Standards
Develop and maintain SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TFLs)
Perform quality control (QC) of SDTM, ADaM datasets, and TFLs
Ensure compliance with CDISC standards and regulatory requirements
Documentation & Study Support
Generate and maintain:
Define XML/PDFs
Analysis Results Metadata (ARM)
Annotated Case Report Forms (eCRFs)
Reviewers’ Guides for SDTM and ADaM datasets
Develop dataset specifications (SDTM and ADaM) with support from senior staff
Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective
Quality, Compliance & Audit Support
Support responses to QA reviews and client audits
Ensure programming deliverables meet regulatory and internal quality standards
Maintain adherence to SOPs and programming guidelines
Qualifications
Bachelor’s degree in Mathematics, Statistics, Computer Science, Life Sciences, Health Sciences, or related field
Equivalent education and experience may be considered in lieu of a degree
Required Experience
4+ years of SAS programming experience in CRO or pharmaceutical industry
Strong knowledge of CDISC standards (SDTM, ADaM)
Experience in clinical trial data programming and analysis deliverables
Skills & Competencies
Strong proficiency in SAS programming
Understanding of clinical data standards and regulatory requirements
Ability to manage multiple study timelines and priorities
Strong analytical and problem-solving skills
Effective communication and collaboration with cross-functional teams
Attention to detail and commitment to data quality
Work Environment & Travel
Office-based or home-based work depending on manager assignment
Approximately 5% travel required (domestic/regional), mainly for client meetings and trainings
Role Summary
This role is central to clinical trial data analysis and reporting, ensuring that high-quality statistical programming outputs are delivered in compliance with global clinical research standards. It requires strong SAS expertise, leadership capability, and a deep understanding of CDISC-based clinical data structures.
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