Principal Statistical Programmer

Parexel International; Remote; USD 100,000 - 130,000; Full time

Job summary

A leading clinical research organization seeks a Principal Statistical Programmer to lead the analysis and reporting of clinical trial data. This senior-level position involves providing strategic programming leadership, ensuring high-quality deliverables, and mentoring team members. The ideal candidate has extensive experience in SAS programming and a background in clinical trials. This role is fully remote, offering competitive compensation and the opportunity to influence global studies.

Qualifications

• Expert in SAS programming with a proven record in statistical programming.
• Experience leading teams in clinical programming environments.
• Strong command of written and spoken English.

Responsibilities

• Lead programming teams to ensure project delivery on time and budget.
• Develop and QC SDTM, ADaM datasets and analysis outputs.
• Mentor team members and share knowledge across the department.

Skills

Advanced SAS programming expertise

Strong analytical and problem-solving skills

Project management capabilities

Excellent communication and influencing skills

Education

Bachelor's degree in Statistics, Computer Science, Mathematics, or Life Sciences

Job description

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.

We’re looking for a candidate with strong EDA, exploratory data analysis skills, someone who can build programs and analytical solutions from the ground up. The ideal person is innovative, curious, and able to think creatively when diving into complex datasets to uncover meaningful insights.

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.

#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.