Parexel · 10 hours ago
Principal Statistical Programmer
United States
Full-time
Remote
Lead/StaffParexel is a company dedicated to improving the world's health through clinical trials and regulatory consulting. They are seeking a Principal Statistical Programmer to lead global studies and ensure high-quality, regulatory-compliant deliverables across multiple studies and therapeutic areas.
Pharmaceuticals
Responsibilities
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
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
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
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
Qualification
Required
Must have experience supporting Medical Affairs and utilizing R
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
Preferred
Experience supporting clinical trials across therapeutic areas is highly desirable
Company
Parexel
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.
Founded in 1983
10001+ employees
H1B Sponsorship
Parexel has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (33)
2024 (46)
2023 (41)
2022 (51)
2021 (54)
2020 (33)
Funding
Current Stage
Late StageLeadership Team
Amy France
SVP, CFO - Consulting & Commercial
Carlos Daniel Garcia
VP Chief Financial Officer - Medical Scientific Services Business Unit
Recent News
2024-04-27
2024-04-07
Company data provided by crunchbase