Job Title:
Principal Statistical Programmer
Location:
IND – Remote
Job ID:
25101956
Updated:
September 29, 2025
Company:
Syneos Health® – fully integrated biopharmaceutical solutions organization
Job Summary:
The Principal Statistical Programmer will lead statistical programming activities for clinical trials, develop analysis datasets, tables, listings, and graphs, and ensure compliance with regulatory and industry standards (CDISC, ICH). This role includes project leadership, mentoring junior programmers, and providing subject matter expertise in statistical programming and clinical trial processes.
Key Responsibilities:
Programming & Analysis
Develop custom programming code in SAS or other software to generate summary tables, listings, graphs, and derived datasets according to the statistical analysis plan (SAP) and programming specifications.
Perform validation programming and resolve discrepancies with biostatisticians and project teams.
Review project documentation including SAP, mock shells, programming specifications, annotated CRFs, and database design.
Maintain complete, organized, and inspection-ready documentation, testing, and QC files.
Project & Team Leadership
Lead programming activities for teams and monitor progress on deliverables.
Manage multiple concurrent projects, prioritizing tasks, setting goals, and adapting to timeline changes.
Conduct effective internal meetings, distribute agendas, follow up on action items, and maintain project focus.
Mentor and train junior programming personnel, including reviewing work and providing guidance.
Regulatory & Standards Compliance
Apply knowledge of CDISC standards for regulatory submissions (SDTM, ADaM, DEFINE.XML).
Conduct compliance reviews of project deliverables for regulatory requirements.
Serve as a technical expert and provide guidance and training on CDISC standards across the organization.
Stay updated on industry standards and actively participate in relevant professional organizations.
Collaboration & Communication
Participate in sponsor meetings, kickoffs, and bid defense meetings as statistical programming representative.
Communicate effectively with team members and stakeholders on programming progress and issues.
Assist with cross-functional initiatives and support business needs as required.
Additional Responsibilities
Contribute to the development of programming tools, macros, SOPs, and process improvements.
Transfer deliverables and perform other work-related duties as assigned.
Minimal travel may be required.
Qualifications:
Undergraduate degree in scientific or statistical discipline; equivalent combination of education and experience considered.
Extensive programming experience in SAS or other software, preferably in clinical trials.
Knowledge of CDISC standards and experience with regulatory submissions preferred.
Experience mentoring others in clinical trial processes and CDISC standards.
Excellent written and verbal communication skills.
Proficiency in English.
Skills & Competencies:
Advanced statistical programming and analytical skills.
Leadership and mentorship capability.
Ability to manage complex, multi-project workloads.
Strong knowledge of regulatory requirements and industry standards.
Problem-solving, process improvement, and organizational skills.
Company Overview:
Syneos Health® has over 29,000 employees across 110 countries. The company provides clinical development, medical affairs, and commercial solutions, emphasizing patient-centered innovation and accelerating therapy delivery.
Website: www.syneoshealth.com
Diversity & Inclusion:
Syneos Health is committed to creating a diverse, inclusive, and authentic workplace. Applicants with transferable skills are encouraged to apply. Reasonable accommodations are provided for employees or applicants with disabilities.
Job Category:
Technology & Engineering / Statistical Programming
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