Principal Statistical Programmer (ADAM & TLF) – Structured Job Format
Job Overview
Position: Principal Statistical Programmer (ADAM & TLF)
Company: Syneos Health
Location: IND-Remote
Job ID: 25108564
Updated: May 22, 2026
Department: Statistical Programming / Clinical Solutions
Work Mode: Remote
About the Company
Syneos Health is a global life sciences services organization supporting pharmaceutical and biotechnology companies across the drug development and commercialization lifecycle.
Company achievements:
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 sites
Role Summary
The Principal Statistical Programmer (ADAM & TLF) is a senior-level programming expert responsible for:
Leading statistical programming activities
Developing ADaM datasets and TLFs
Establishing programming standards and best practices
Providing technical leadership and mentorship
Managing sponsor-facing programming deliverables
Supporting clinical study reporting and regulatory compliance
This role requires extensive experience in Clinical SAS programming and expertise in ADaM and TLF development for clinical trials.
Key Responsibilities
Statistical Programming Leadership
Develop and maintain:
Statistical programming standards
Best practices
Programming processes
Provide technical expertise and leadership for study programming activities
ADaM & TLF Programming
Develop:
ADaM datasets
TLFs (Tables, Listings, Figures)
ADaM specifications
Ensure outputs meet sponsor and regulatory expectations
Data Integrity & Quality Control
Ensure:
Accuracy of datasets
Integrity of statistical outputs
Compliance with programming standards
Troubleshoot and resolve complex programming issues
Process Improvement
Design efficient programming solutions
Improve workflows and productivity
Contribute to optimization of tools and processes
Team Collaboration
Collaborate with:
Statisticians
Clinical teams
Sponsors
Cross-functional stakeholders
Translate business and statistical requirements into technical deliverables
Code Review & Mentoring
Conduct code reviews
Provide technical feedback and guidance
Mentor and train junior programmers
Technical Innovation
Stay current with:
Statistical programming trends
SAS advancements
Industry standards
Incorporate relevant modern techniques into workflows
Required Qualifications
Experience
Minimum 8+ years of experience in:
Clinical SAS
Base SAS
Advanced SAS
Mandatory Expertise
Strong experience in:
ADaM programming
TLF development
Dataset generation
ADaM specifications
Preferred Experience
ISS/ISE or pooled study experience
Safety and efficacy data programming
Sponsor/client handling experience
Leading studies independently
Technical Skills
Programming Languages & Tools
SAS (mandatory)
R (preferred)
Python (preferred)
Core Technical Areas
Clinical trial data programming
Statistical analysis support
Dataset creation and validation
Regulatory reporting deliverables
Specialized Knowledge
ADaM standards
TLF creation
Statistical methods
Data analysis techniques
Certifications
Preferred:
SAS Certified Advanced Programmer for SAS 9
OR
Equivalent SAS certification
Soft Skills
Strong communication and interpersonal abilities
Excellent analytical and problem-solving skills
Leadership and mentoring capability
Ability to work independently and collaboratively
Strong stakeholder and client management skills
Seniority & Impact
Role Level
Principal / Senior Expert Individual Contributor (P23 level)
Impact Areas
Cross-functional project leadership
Programming process optimization
Study-level delivery ownership
Mentorship and technical guidance
Organizational programming standards
Functional Areas Covered
Statistical Programming
Clinical SAS
ADaM Development
TLF Programming
Clinical Data Analytics
Regulatory Reporting
Preferred Competencies
End-to-end study management
Regulatory submission support
Sponsor-facing communication
Team leadership and mentoring
Quality review and inspection readiness
Work Environment & Culture
Why Join Syneos Health?
Career progression and development opportunities
Technical and therapeutic-area training
Inclusive and collaborative workplace
Global clinical research exposure
Recognition and rewards programs
Ideal Candidate Profile
The ideal candidate should:
Be highly proficient in SAS and ADaM/TLF programming
Have strong leadership and mentoring experience
Handle sponsor interactions confidently
Lead complex clinical programming studies independently
Drive quality, efficiency, and innovation in programming deliverables
Employment Notes
Additional duties may be assigned as required
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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