Job Title: Principal Statistical Programmer (Lead SAS Programmer – CDISC, SDTM, ADaM)
Location: Bangalore / Pune / Mumbai / Remote – India
Job Type: Full-Time
Job ID: 26398
Posted: 10 Days Ago
Application Deadline: April 30, 2026
Job Category: Biostatistics / Statistical Programming / Clinical Data Science / Clinical Research
Job Overview
We are seeking an experienced Principal Statistical Programmer to serve as Lead Statistical Programmer on complex clinical research studies. This senior-level role is responsible for overseeing end-to-end statistical programming activities, ensuring high-quality CDISC-compliant deliverables, and leading cross-functional collaboration within global clinical trial environments.
The selected candidate will provide technical leadership in SAS programming, SDTM and ADaM dataset development, TFL generation, and regulatory submission support while mentoring junior programmers and contributing to business development initiatives.
Experience Required
Minimum 6+ years of SAS programming experience within the CRO or pharmaceutical industry
Proven experience as Lead Statistical Programmer on complex clinical studies
Strong expertise in CDISC standards, including SDTM, ADaM, Define.xml, and regulatory submission requirements
Key Responsibilities
Act as Lead Statistical Programmer across assigned clinical trials
Plan, execute, and oversee all programming activities, including resource estimation, budgeting, timeline management, and quality oversight
Develop and maintain SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TFLs)
Perform quality control (QC) of SDTM, ADaM, and TFL outputs
Generate Define XML/PDF files, Analysis Results Metadata (ARM), annotated CRFs (aCRFs), and Reviewer’s Guides
Lead development of complex SDTM and ADaM specifications
Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective
Advise on and support the development of complex TFL shells
Mentor and guide junior statistical programmers to ensure adherence to CDISC standards and departmental processes
Support QA inspections, client audits, and regulatory qualification audits
Participate in proposal development and bid defense meetings to support new business acquisition
Identify and implement process improvements to enhance programming efficiency and quality
Required Qualifications
Bachelor’s degree in Mathematics, Statistics, Computer Science, Life Sciences, Health Sciences, or a related discipline
Equivalent education and relevant professional experience may be considered
Strong English communication skills (spoken and written)
In-depth understanding of the full clinical trial lifecycle, from study start-up to submission
Excellent knowledge of cross-functional roles including Biostatistics and Clinical Data Management
Comprehensive knowledge of CDISC standards, including:
SDTM
ADaM
Define.xml
Reviewer’s Guides
Regulatory submission standards
Preferred Competencies
Strong leadership and mentoring capabilities
Experience contributing to client interactions and strategic project discussions
Ability to manage multiple studies simultaneously
Strong analytical and problem-solving skills
Process improvement mindset with a focus on quality and compliance
Work Environment
Office-based or home-based (remote) work environment within India, as per line manager direction
Collaborative engagement with global clinical research teams
Why Apply?
This is a senior-level statistical programming leadership opportunity within global clinical research. The role provides exposure to complex regulatory submissions, CDISC implementation, cross-functional collaboration, and strategic project oversight, making it ideal for experienced SAS programmers seeking advancement in biostatistics and clinical data science.
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Siliguri |Illinois :
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