Principal Statistical Programmer (ADaM & TLF) – Job Summary
Company: Syneos Health
Job Title: Principal Statistical Programmer (ADaM & TLF)
Job ID: 25108564
Location: Remote (India)
Department: Biostatistics & Statistical Programming
Experience Required: 8+ Years
Employment Type: Full-Time
Role Overview
The Principal Statistical Programmer serves as a technical leader responsible for ADaM dataset development, TLF generation, programming standards, and study-level statistical programming delivery. This role involves leading complex clinical trial programming activities, mentoring programmers, collaborating with statisticians and sponsors, and ensuring high-quality regulatory-compliant deliverables.
The position requires strong expertise in Clinical SAS, ADaM, TLF programming, study leadership, and client management across safety and efficacy studies.
Key Responsibilities
Statistical Programming Leadership
Lead statistical programming activities across multiple clinical studies.
Design, develop, and validate:
ADaM datasets
Tables, Listings, and Figures (TLFs)
Analysis datasets
Regulatory submission outputs
Develop efficient and scalable programming solutions.
Standards & Process Development
Establish and maintain statistical programming standards and best practices.
Contribute to process optimization and automation initiatives.
Ensure consistency across studies and programming deliverables.
Study & Client Management
Serve as the primary programming lead for assigned studies.
Collaborate with:
Statisticians
Data Management Teams
Clinical Teams
Sponsors and Clients
Manage client interactions and provide technical consultation.
Lead study-level planning, execution, and delivery activities.
Quality & Compliance
Ensure data integrity and accuracy of programming outputs.
Perform code reviews and quality assessments.
Troubleshoot and resolve programming challenges.
Ensure compliance with:
CDISC Standards
ICH Guidelines
Regulatory requirements
Company SOPs
Team Leadership & Mentoring
Mentor and train junior and mid-level programmers.
Provide technical guidance on complex programming issues.
Conduct knowledge-sharing sessions and training programs.
Support capability development within the programming team.
Required Qualifications
Education
Bachelor's or Master's degree in:
Statistics
Mathematics
Computer Science
Life Sciences
Related Scientific Discipline
Experience
8+ years of Clinical SAS Programming experience.
Strong experience in:
ADaM specifications
ADaM dataset generation
TLF development
Clinical trial data analysis
Proven experience leading studies and handling clients.
Experience managing end-to-end programming deliverables.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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