Principal Statistical (R) Programmer – North America Only
Location: Morrisville, North Carolina, United States
Region Eligibility: United States and Canada (No visa sponsorship available)
Employment Type: Full-Time
Travel Requirement: Minimal
Experience Required: 8–12+ Years in Statistical Programming within Clinical Trials
Job ID: 25105752-OTHLOC-1500-2DOR-2DR
About the Organization
Syneos Health is a fully integrated biopharmaceutical solutions organization that supports pharmaceutical and biotechnology companies across clinical development, medical affairs, and commercialization. With a global workforce operating in more than 100 countries, Syneos Health contributes to a significant percentage of FDA- and EMA-approved therapies worldwide.
Role Summary
The Principal Statistical (R) Programmer is a senior-level expert responsible for leading statistical programming strategy and execution for complex regional and global clinical trials. This role combines deep expertise in R and SAS programming with advanced knowledge of CDISC standards, regulatory submission requirements, and cross-functional leadership.
The position is open exclusively to candidates authorized to work in North America without sponsorship.
Core Responsibilities
Advanced Statistical Programming
Develop and validate complex R programs to generate analysis datasets, tables, listings, and figures (TLFs) aligned with Statistical Analysis Plans (SAPs)
Design and implement derived datasets in accordance with CDISC SDTM and ADaM standards
Ensure high-quality, reproducible outputs that meet sponsor and regulatory expectations
Perform independent validation programming and discrepancy resolution
Regulatory & CDISC Compliance
Serve as subject matter expert (SME) for CDISC standards, including SDTM, ADaM, and Define.xml
Conduct compliance reviews for regulatory submissions to FDA and other global agencies
Maintain inspection-ready documentation aligned with ICH and internal SOPs
Stay current with evolving regulatory and industry standards
Project Leadership & Oversight
Act as Lead Statistical Programmer on multi-study or global clinical programs
Direct programming activities of team members and monitor deliverables
Manage concurrent project timelines and negotiate priorities with stakeholders
Identify risks proactively and implement mitigation strategies
Represent statistical programming in sponsor meetings, bid defenses, and kickoff sessions
Process Optimization & Mentorship
Mentor and train statistical programming staff on clinical trial processes and CDISC implementation
Develop standardized macros, automation tools, and reusable programming frameworks
Contribute to SOP development and departmental best practices
Participate in internal and external industry standards initiatives
Cross-Functional Collaboration
Partner with Biostatistics, Data Management, Clinical Operations, and Regulatory teams
Review SAPs, annotated CRFs, database structures, and programming specifications to improve efficiency
Maintain transparent communication regarding project progress and technical challenges
Educational Qualifications
Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or related scientific discipline
Advanced degree preferred
Equivalent combination of education and demonstrated programming leadership experience may be considered
Required Experience & Technical Expertise
8–12+ years of statistical programming experience in a clinical trial environment
Extensive hands-on experience with R and SAS programming
Proven leadership on complex, global clinical studies
Strong expertise in CDISC standards (SDTM, ADaM) and electronic submission requirements
Experience supporting FDA or international regulatory submissions preferred
Demonstrated experience mentoring programming teams
Comprehensive understanding of the clinical drug development lifecycle
Key Competencies
Advanced analytical and data interpretation skills
Strong project management and organizational abilities
Excellent written and verbal communication skills
Ability to manage multiple high-priority deliverables
High attention to regulatory compliance and data integrity
Compensation & Benefits
Compensation is competitive and based on qualifications, experience, geographic location, and technical proficiency. Benefits may include medical, dental, and vision insurance, retirement savings plans (401k with company match), employee stock purchase eligibility, performance-based bonuses, flexible paid time off, and additional region-specific benefits in compliance with applicable federal and state regulations.
Equal Employment Opportunity
Syneos Health is committed to equal employment opportunity and compliance with all applicable employment laws. Reasonable accommodations are available for qualified applicants under the Americans with Disabilities Act (ADA) and other relevant regulations.
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