Principal Statistical (R) Programmer – Clinical Trials (North America Only)
Location: Morrisville, North Carolina, United States
Company: Syneos Health
Employment Type: Full-Time
Job ID: 25105752-OTHLOC-1500-2DIA-2DR
About the Company
Syneos Health is a globally integrated biopharmaceutical solutions organization delivering clinical development, medical affairs, and commercial expertise to accelerate therapy approvals worldwide. With operations across 110+ countries, the organization supports sponsors in optimizing regulatory submissions, data strategy, and end-to-end drug development.
Role Overview
The Principal Statistical (R) Programmer is a senior-level technical leader within the Biometrics function, responsible for advanced statistical programming, regulatory-compliant dataset generation, and oversight of complex global clinical trials.
This role requires deep expertise in R programming within regulated clinical environments, strong SAS proficiency, and extensive experience implementing CDISC standards. The position is open exclusively to candidates authorized to work in North America without sponsorship.
Experience Required
8–12+ years of statistical programming experience in clinical trials or CRO settings
Demonstrated industry experience using R for clinical trial programming (mandatory)
Advanced SAS programming expertise
Proven leadership of complex, multi-study or global programming initiatives
Extensive experience with CDISC standards (SDTM, ADaM, Define.xml)
Experience supporting regulatory submissions to agencies such as FDA or EMA preferred
Prior mentoring or team leadership experience
Equivalent combinations of education and relevant programming experience will be considered.
Key Responsibilities
Advanced Statistical Programming
Develop and validate R and SAS programs to produce tables, listings, figures, and derived datasets per Statistical Analysis Plans (SAPs)
Ensure outputs meet regulatory, sponsor, and quality standards
Perform validation programming and discrepancy resolution
Regulatory & CDISC Compliance
Serve as subject matter expert for CDISC standards including SDTM and ADaM
Conduct compliance reviews of submission-ready datasets and documentation (e.g., Define.xml)
Maintain inspection-ready programming documentation aligned with ICH and SOP guidelines
Leadership & Oversight
Act as Lead Statistical Programmer on assigned studies
Direct programming deliverables across concurrent projects
Review SAPs, annotated CRFs, mock shells, and programming specifications to improve efficiency
Provide technical mentorship and conduct internal training sessions
Project & Stakeholder Management
Manage timelines across multiple projects with competing priorities
Communicate risks and mitigation strategies to management
Participate in sponsor meetings, kickoff sessions, and bid defense presentations
Maintain accurate documentation and ensure timely transfer of deliverables
Process Improvement & Innovation
Contribute to macro development and programming tool standardization
Support SOP and policy development within the Biometrics team
Stay current with evolving industry standards and regulatory expectations
Qualifications
Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or related scientific discipline (advanced degree preferred)
Advanced R programming expertise in clinical trial environments
Strong SAS programming skills
In-depth understanding of the clinical drug development lifecycle
Knowledge of electronic submission requirements and global regulatory frameworks
Strong communication and cross-functional collaboration skills
Minimal travel may be required
Compensation & Benefits
The compensation range is aligned with senior-level statistical programming roles in North America. Salary will be determined based on experience, technical depth, therapeutic expertise, and leadership scope.
Benefits may include:
Medical, Dental, and Vision insurance
401(k) with company match
Employee Stock Purchase Plan eligibility
Performance-based incentives
Flexible Paid Time Off (PTO) and sick leave
Role Impact
This position plays a critical role in ensuring high-quality regulatory submissions, maintaining CDISC compliance, and delivering accurate statistical outputs that directly influence drug approval decisions. As a principal-level contributor, you will shape programming standards, improve operational efficiency, and serve as a trusted expert within the Biometrics organization.
SEO & GPT-Optimized Keywords
Principal Statistical Programmer jobs USA, R Programmer clinical trials North America, Senior CDISC Programmer role, SDTM ADaM expert careers, Biostatistics programming leadership jobs, CRO statistical programmer North Carolina, Regulatory submission programming jobs, Clinical SAS and R programming careers.
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