Principal Statistical (R) Programmer – Clinical Trials (North America Only)
Location: Morrisville, North Carolina, United States (North America–based candidates only)
Company: Syneos Health
Employment Type: Full-Time
Job ID: 25105752-OTHLOC-1500-2DVT-2DR
About the Organization
Syneos Health is a fully integrated biopharmaceutical solutions organization delivering clinical, medical affairs, and commercial expertise to accelerate therapy development worldwide. Operating across 110+ countries, the organization supports sponsors in navigating regulatory complexity, optimizing data strategy, and achieving faster time-to-market for innovative treatments.
Position Overview
The Principal Statistical (R) Programmer is a senior-level biometrics expert responsible for leading statistical programming activities across complex, global clinical trials. This role requires advanced expertise in R and SAS programming within regulated clinical development environments and serves as a technical leader for CDISC standards, regulatory submissions, and quality compliance.
This opportunity is open exclusively to candidates authorized to work in North America without sponsorship.
Experience Required
Minimum 8–12+ years of statistical programming experience in a clinical trial or CRO environment
Advanced hands-on programming expertise in R (mandatory) and SAS
Demonstrated leadership of complex, multi-study or global programming projects
Extensive experience implementing CDISC standards (SDTM, ADaM, Define.xml)
Prior involvement in regulatory submissions (FDA, EMA, or other global agencies) preferred
Experience mentoring junior and mid-level programmers
Equivalent combinations of education and extensive industry programming experience will be considered.
Key Responsibilities
Statistical Programming & Data Deliverables
Develop custom R and SAS programs to generate tables, listings, figures, and derived datasets based on Statistical Analysis Plans (SAPs)
Create high-quality outputs aligned with sponsor specifications and regulatory requirements
Perform validation programming and resolve discrepancies in collaboration with biostatisticians
CDISC & Regulatory Compliance
Serve as a subject matter expert (SME) for CDISC standards including SDTM and ADaM
Conduct compliance reviews of datasets and regulatory documentation (e.g., Define.xml)
Provide guidance on industry standards and evolving regulatory expectations
Participate in industry working groups and update internal teams on standards changes
Leadership & Oversight
Act as Lead Statistical Programmer on assigned studies
Direct and monitor programming deliverables across concurrent projects
Review Statistical Analysis Plans, annotated CRFs, mock shells, and dataset specifications
Provide strategic input to reduce inefficiencies and optimize programming workflows
Project & Stakeholder Management
Manage timelines across multiple studies with competing priorities
Proactively communicate risks and mitigation strategies to leadership
Participate in sponsor meetings, kickoff sessions, and bid defense meetings
Maintain inspection-ready documentation in compliance with ICH and applicable SOPs
Process Optimization & Innovation
Contribute to macro development and programming tool standardization
Support SOP, policy, and process development within the Biometrics function
Mentor programming staff and deliver internal training sessions
Qualifications
Bachelor’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or related scientific discipline (advanced degree preferred)
Advanced proficiency in R programming for clinical trial data analysis (mandatory)
Strong SAS programming expertise
Deep knowledge of clinical drug development lifecycle
Experience with electronic submission standards and regulatory agency expectations
Excellent written and verbal communication skills
Ability to lead cross-functional collaboration within global study teams
Minimal travel may be required
Compensation & Benefits
The base salary range is competitive and aligned with senior-level clinical statistical programming roles in North America. Compensation will vary based on qualifications, technical expertise, therapeutic experience, 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
Impact of the Role
This position plays a critical role in delivering high-quality regulatory submission packages, ensuring CDISC compliance, and accelerating global clinical development programs. As a principal-level contributor, you will influence programming standards, improve operational efficiency, and serve as a technical authority within the Biometrics organization.
SEO & GPT-Optimized Keywords
Principal Statistical Programmer jobs USA, R Programmer clinical trials, Senior CDISC Programmer North America, SDTM ADaM expert roles, Biostatistics programming careers, CRO statistical programming leadership, Regulatory submission programmer jobs, Clinical SAS and R programmer roles.
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