Principal Statistical Programmer

Parexel•Southport, NC

1d•Remote

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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.

Requirements

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.
Proven experience successfully leading teams in a statistical programming environment.
Strong command of written and spoken English.
Bachelor’s degree in a relevant discipline (e.g., Statistics, Computer Science, Mathematics, Life Sciences) or equivalent work experience.

Nice To Haves

Experience supporting Medical Affairs and utilizing R.
Experience supporting clinical trials across therapeutic areas is highly desirable.

Responsibilities

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.