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Principal Statistical Programmer

Software EngineerSoftware EngineerOtherRemoteLeadTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

124 days ago

Salary

0

Seniority

Lead

Bachelor DegreeEnglishGCP

Job Description

Principal Statistical Programmer

Parexel

• 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. • 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.

Job Requirements

  • 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.
  • 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.

Benefits

  • Health insurance
  • Professional development opportunities

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