Principal Statistical Programmer

Location: Remote
Type: Full-Time

Are you an expert Statistical Programmer looking to lead global studies, shape best practices, and serve as a trusted consultant to sponsors? Join our team as a Principal Statistical Programmer and play a critical role in the analysis and reporting of clinical trial data. In this senior-level position, you will act as a subject matter expert, provide strategic programming leadership, and ensure high-quality, regulatory-compliant deliverables across multiple studies and therapeutic areas. Must have experience supporting Medical Affairs and utilizing R.

Key Accountabilities

🔹 Strategic Leadership & Project Management

• Serve as Statistical Programming Lead on assigned projects.
• Lead programming teams to deliver high‑quality outputs within agreed timelines and budget.
• Drive project planning activities including start-up, resource allocation, and development of global programs and tracking tools.
• Review statistical analysis plans (SAPs), mock shells, and database specifications.
• Partner closely with sponsors, Biostatistics Leads, Data Management, and other stakeholders.
• Monitor scope, resources, productivity, and project financials.
• Support issue resolution and ensure smooth day‑to‑day study execution.

🔹 Statistical Programming & Quality Delivery

• Develop and QC SDTM, ADaM datasets, analysis outputs, tables, listings, and figures.
• Create and QC dataset specifications, study-level documentation, and regulatory submission materials.
• Ensure all programming activities meet corporate quality standards, SOPs, ICH‑GCP, and regulatory requirements.
• Demonstrate consistent first-time quality in deliverables through rigorous QC practices.

🔹 Training, Mentorship & Knowledge Sharing

• Maintain and deepen knowledge of global clinical and regulatory standards.
• Mentor team members and provide project-specific training.
• Lead knowledge-sharing initiatives across the department.
• Expand understanding of internal processes, SAS techniques, and cross-functional workflows.

🔹 Operational Excellence & Compliance

• Maintain study documentation to ensure traceability and regulatory readiness.
• Participate in audits and inspections as needed.
• Contribute to process improvement, technology assessments, and operational optimization.
• Provide expert programming consultancy to sponsors.
• Represent Statistical Programming on cross-functional initiatives and external meetings.

Skills & Competencies

• Advanced SAS programming expertise.
• Strong analytical and problem‑solving skills.
• Deep understanding of clinical programming standards (e.g., CDISC, 21 CFR Part 11).
• Strong project management capabilities with the ability to manage competing priorities.
• Excellent organizational skills and attention to detail.
• Ability to lead and mentor global teams effectively.
• Strong business acumen, financial awareness, and client-focused approach.
• Excellent communication, presentation, negotiation, and influencing skills.
• Ability to adapt and learn new systems in an evolving technical environment.
• Demonstrated commitment to quality and continuous improvement.

Knowledge & Experience

• Proven experience successfully leading teams in a statistical programming environment.
• Strong command of written and spoken English.
• Experience supporting clinical trials across therapeutic areas is highly desirable.

Education

• Bachelor’s degree in a relevant discipline (e.g., Statistics, Computer Science, Mathematics, Life Sciences) or equivalent work experience.