Job Title:
Stat II / Senior / Principal Statistical Programmer (R / R Shiny)
Location:
IND – Remote
Job ID:
25101962
Updated:
September 29, 2025
Company:
Syneos Health® – a fully integrated biopharmaceutical solutions organization
Job Summary:
The Statistical Programmer will develop programs and provide statistical programming support for statisticians, clients, and internal teams. This includes creating analysis datasets, tables, listings, and graphs, validating outputs, and ensuring compliance with CDISC standards and regulatory requirements. The role may lead complex projects, mentor other programmers, and contribute to process improvement initiatives.
Key Responsibilities:
Programming & Analysis
Develop custom programming code in SAS, R, or other software to generate summary tables, listings, graphs, and derived datasets as per statistical analysis plan (SAP) and programming specifications.
Conduct validation programming and resolve discrepancies with team members.
Review statistical programming deliverables for accuracy, completeness, and compliance with SOPs and regulatory guidelines (e.g., ICH).
Prepare well-organized documentation, testing records, and verification/QC files for inspection readiness.
Project & Team Management
Manage multiple projects concurrently, prioritize tasks, and adapt to changes in timelines or project priorities.
Lead programming activities for teams, direct workflow, and monitor deliverables.
Conduct internal meetings, distribute agendas, follow up on action items, and maintain project focus.
Provide mentorship, guidance, and training to junior programming staff.
Regulatory & Standards Compliance
Apply knowledge of CDISC standards for regulatory submissions (SDTM, ADaM, DEFINE.XML).
Perform compliance reviews of project deliverables per regulatory requirements.
Serve as a subject matter expert for CDISC and other industry standards; provide guidance and training across departments.
Stay updated on industry standards and participate in relevant professional organizations.
Collaboration & Communication
Work closely with statisticians, programmers, and other team members to ensure high-quality deliverables.
Participate in sponsor meetings, project kick-offs, and bid defense meetings as the programming representative.
Maintain clear, professional communication across teams and stakeholders.
Additional Responsibilities
Develop and improve programming tools and macros to increase standardization and efficiency.
Contribute to SOPs, guidelines, and internal policies.
Perform other duties as assigned; minimal travel may be required.
Qualifications:
Undergraduate degree in a scientific, statistical, or related discipline; equivalent combination of education and experience considered.
Extensive experience in SAS or other programming software, preferably in clinical trials.
Knowledge and experience with CDISC standards for regulatory submissions.
Experience mentoring other programmers in clinical trial processes and CDISC standards.
Excellent written and verbal communication skills.
Proficiency in English.
Skills & Competencies:
Advanced programming and statistical skills.
Ability to manage multiple complex projects simultaneously.
Leadership and mentorship capability.
Strong problem-solving and analytical skills.
Knowledge of regulatory requirements for clinical trials.
Company Overview:
Syneos Health® is a leading biopharmaceutical solutions company with over 29,000 employees in 110 countries. The company focuses on 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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