Parexel

Principal Statistical Programmer

Parexel

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • 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.

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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAS programmingSDTMADaMstatistical analysis plansdataset specificationsregulatory submission materialsdata managementproject planningquality controlprocess improvement
Soft Skills
leadershipanalytical skillsproblem-solvingproject managementorganizational skillsattention to detailmentoringcommunication skillspresentation skillsclient-focused approach