Programming Lead – Statistical Programming
Location: Bangalore, India
Employment Type: Full-Time
Job ID: 261995
Job Overview
The Programming Lead is responsible for leading statistical programming activities across clinical studies, ensuring high-quality deliverables, regulatory compliance, and adherence to timelines and budgets.
This role involves end-to-end oversight of study programming, technical leadership, mentoring junior programmers, and direct collaboration with cross-functional teams and clients.
Key Responsibilities
Study Leadership & Planning
Act as Lead Statistical Programmer for assigned studies
Plan and oversee all programming activities, including:
Resource planning and estimation
Budget and timeline management
Quality assurance and delivery oversight
Coordinate with internal teams and external clients to ensure alignment on deliverables
SAS Programming & Data Deliverables
Develop and maintain SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TFLs)
Perform quality control (QC) of SDTM, ADaM datasets, and TFL outputs
Ensure compliance with CDISC standards and regulatory requirements
Documentation & Submission Support
Generate and maintain:
Define XML/PDFs
Analysis Results Metadata (ARM)
Annotated Case Report Forms (aCRFs)
Reviewers’ Guides for SDTM and ADaM datasets
Develop SDTM and ADaM dataset specifications
Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective
Leadership & Mentorship
Mentor and guide junior and mid-level programmers
Share knowledge through departmental meetings and training sessions
Promote best practices in statistical programming and CDISC implementation
Quality, Compliance & Process Improvement
Respond to QA audits and client inspections
Support qualification and regulatory audits
Identify and implement process improvements to enhance productivity, efficiency, and quality
Ensure adherence to SOPs and regulatory guidelines
Qualifications
Bachelor’s degree in Mathematics, Statistics, Computer Science, Life Sciences, Health Sciences, or related field
Equivalent education and experience may be considered
Required Experience
Minimum 5 years of SAS programming experience in CRO or pharmaceutical industry
Strong knowledge of CDISC standards (SDTM, ADaM)
Proven experience in clinical trial statistical programming deliverables
Skills & Competencies
Advanced SAS programming expertise
Strong leadership and mentoring capability
Deep understanding of clinical data standards and regulatory expectations
Excellent problem-solving and analytical skills
Strong communication and stakeholder management abilities
Ability to manage multiple studies and priorities simultaneously
Work Environment & Travel
Office or home-based work depending on manager assignment
Approximately 5% travel required (domestic/regional), primarily for client meetings and trainings
Role Summary
This role provides technical leadership in clinical statistical programming, ensuring high-quality CDISC-compliant datasets and analysis outputs. It combines hands-on programming expertise with team leadership, client interaction, and process improvement responsibilities.
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