Principal Statistical Programmer (ADAM & TLF) – Structured Job Format
Job Overview
Position: Principal Statistical Programmer (ADAM & TLF)
Company: Syneos Health
Location: Hyderabad (Hybrid)
Job ID: 25108564
Updated: May 22, 2026
Department: Statistical Programming / Clinical Solutions
Work Mode: Hybrid
About the Company
Syneos Health is a fully integrated life sciences services organization that supports customers across the entire drug development and commercialization continuum.
Company highlights:
Supported 94% of novel FDA-approved drugs in the last 5 years
Worked on 95% of EMA-authorized products
Managed 200+ studies across 73,000+ global clinical sites
Role Summary
The Principal Statistical Programmer (ADAM & TLF) is a senior-level statistical programming role responsible for:
Leading statistical programming activities
Developing ADaM datasets and TLFs
Providing technical leadership and mentorship
Managing study-level programming deliverables
Collaborating with statisticians, sponsors, and cross-functional teams
The role requires deep expertise in Clinical SAS programming and extensive experience in ADaM and TLF development within clinical trials.
Key Responsibilities
Statistical Programming Leadership
Develop and maintain:
Statistical programming standards
Best practices
Efficient programming workflows
Provide technical leadership to programming teams
ADaM & TLF Development
Create and maintain:
ADaM datasets
TLFs (Tables, Listings, Figures)
ADaM specifications
Ensure datasets and outputs comply with sponsor and regulatory requirements
Data Quality & Validation
Ensure:
Accuracy of statistical outputs
Data integrity
Consistency across deliverables
Troubleshoot and resolve complex programming issues
Study & Client Management
Lead statistical programming activities for studies
Handle direct client interactions
Participate in sponsor discussions and project meetings
Support study planning and execution activities
Process Improvement
Design efficient programming solutions
Improve productivity through automation and optimization
Contribute to continuous improvement initiatives
Code Review & Mentorship
Conduct code reviews
Provide constructive technical feedback
Mentor and train junior programmers and team members
Collaboration & Communication
Work closely with:
Statisticians
Clinical teams
Data management teams
Sponsors
Translate programming requirements into technical solutions
Innovation & Technical Development
Stay updated on:
SAS advancements
Statistical programming technologies
Industry standards
Introduce relevant programming techniques and tools
Required Qualifications
Experience
Minimum 8+ years of experience in:
Clinical SAS
Base SAS
Advanced SAS
Core Expertise
Strong hands-on experience in:
ADaM programming
TLF programming
ADaM specifications
Dataset generation
Additional Preferred Experience
ISS/ISE or pooled study experience
Safety and efficacy data programming
Study leadership and client handling experience
Technical Skills
Programming Languages & Tools
SAS (mandatory)
R (preferred)
Python (preferred)
Domain Knowledge
Clinical trial data standards
Statistical analysis workflows
Regulatory submission requirements
Data validation and QC processes
Specialized Skills
ADaM dataset creation
TLF generation
Statistical programming process optimization
Cross-study pooling and integration
Certifications
Preferred:
SAS Certified Advanced Programmer for SAS 9
OR
Equivalent SAS certification
Soft Skills
Strong communication and interpersonal skills
Leadership and mentoring capabilities
Analytical and problem-solving mindset
Ability to work independently and collaboratively
Strong stakeholder management skills
Preferred Competencies
Sponsor-facing experience
Leading end-to-end studies
Regulatory submission support
Inspection readiness
Team management or project leadership experience
Work Environment & Culture
Why Join Syneos Health?
Strong career development programs
Technical and therapeutic-area training
Collaborative global work environment
Inclusive and diverse culture
Recognition and rewards programs
Exposure to global clinical research projects
Functional Areas Covered
Statistical Programming
ADaM Development
TLF Programming
Clinical SAS
Clinical Trial Analytics
Regulatory Data Reporting
Seniority & Impact
This is a senior-level individual contributor role with:
Cross-functional influence
Study leadership responsibilities
Mentorship and review responsibilities
Strategic contributions to programming standards and processes
The role contributes directly to:
Clinical study success
Programming efficiency
Data quality and regulatory compliance
Ideal Candidate Profile
The ideal candidate should:
Have deep expertise in ADaM and TLF programming
Be highly proficient in SAS programming
Demonstrate strong study leadership capabilities
Be comfortable handling sponsors and clients directly
Mentor and guide junior programmers effectively
Thrive in a collaborative, fast-paced environment
Employment Notes
Additional responsibilities may be assigned as needed
Equivalent qualifications and experience may be considered
Syneos Health is an equal opportunity employer
Reasonable accommodations are available where appropriate
Application
Apply via:
Syneos Health Careers
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