Principal Statistical (R) Programmer – North America Only
Location: Morrisville, North Carolina, United States
Region Eligibility: United States & Canada (Must be authorized to work without sponsorship)
Employment Type: Full-Time
Travel: Minimal
Experience Required: 8+ Years in Statistical Programming within Clinical Trials
About the Company
Syneos Health is a fully integrated biopharmaceutical solutions organization providing clinical development, medical affairs, and commercial services to pharmaceutical and biotechnology companies. With operations across more than 100 countries, Syneos Health supports global drug development and regulatory submissions, partnering on a significant percentage of FDA- and EMA-approved therapies in recent years.
Role Overview
The Principal Statistical (R) Programmer is a senior-level individual contributor and technical lead responsible for delivering high-quality statistical programming outputs using R and SAS in support of global clinical trials. This role requires advanced expertise in CDISC standards, regulatory submissions, and complex statistical analysis plan (SAP) implementation.
The position is restricted to candidates eligible to work in North America without visa sponsorship.
Key Responsibilities
Statistical Programming & Analysis
Develop and validate custom R programming code to generate analysis datasets, tables, listings, and figures (TLFs) as defined in Statistical Analysis Plans (SAPs)
Create complex derived datasets in accordance with CDISC standards (SDTM, ADaM)
Perform validation programming to ensure accuracy, reproducibility, and regulatory compliance
Review annotated CRFs, mock shells, SAPs, and database designs to ensure efficient programming execution
CDISC & Regulatory Expertise
Serve as subject matter expert (SME) for CDISC standards and regulatory submission requirements
Conduct compliance reviews for SDTM, ADaM datasets and Define.xml documentation
Provide guidance on FDA and global regulatory submission standards
Maintain inspection-ready documentation aligned with ICH guidelines and SOPs
Project Leadership & Oversight
Act as lead statistical programmer on complex or global studies
Direct and monitor programming deliverables across concurrent projects
Negotiate timelines and proactively identify risks with mitigation strategies
Represent statistical programming in sponsor meetings, bid defenses, and project kickoffs
Quality Control & Documentation
Maintain complete and audit-ready programming documentation
Ensure outputs meet internal quality standards and sponsor specifications
Follow regulatory guidelines including ICH and applicable global standards
Mentorship & Process Improvement
Mentor and train junior programmers on clinical trial processes and CDISC standards
Develop training materials and contribute to departmental capability building
Support development of standardized macros and programming tools to enhance efficiency
Contribute to SOP development and statistical programming best practices
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 expertise may be considered
Required Experience & Technical Skills
Minimum 8+ years of statistical programming experience in a clinical trial environment
Extensive hands-on expertise in R and SAS programming
Proven experience leading complex, multi-study, or global clinical projects
Strong working knowledge of CDISC standards (SDTM, ADaM) and regulatory submissions
Experience supporting FDA or other global regulatory agency submissions preferred
Demonstrated leadership in mentoring statistical programming teams
Strong understanding of clinical drug development lifecycle
Core Competencies
Advanced analytical and problem-solving skills
Strong cross-functional collaboration capabilities
Excellent written and verbal communication skills
Ability to manage multiple concurrent projects with shifting priorities
High attention to detail and commitment to quality and compliance
Compensation & Benefits
The base salary range for this role varies based on candidate qualifications, technical proficiency, geographic location, and experience level. Compensation may include performance-based incentives, retirement benefits, healthcare coverage (medical, dental, vision), employee stock purchase eligibility, paid time off, and other region-specific benefits in compliance with federal, state, and provincial regulations.
Equal Employment Opportunity
Syneos Health is committed to equal employment opportunity and compliance with applicable federal, state, provincial, and international labor laws. Reasonable accommodations are available for qualified individuals in accordance with the Americans with Disabilities Act (ADA) and other applicable regulations.
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Kyiv |Lima Region :
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Niš |Bohemia :
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