[Hiring] Contract Clinical Trial Statistician @RTI International

Role Description

RTI International is seeking a Contract Senior Clinical Trial Statistician (Sr. Stat) who is a strategic and hands-on leader responsible for overseeing end-to-end analysis activities across multiple clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with Good Clinical Practice (GCP), regulatory guidelines, and company standard operating procedures (SOPs). The Sr. Stat serves as the primary liaison between internal teams, contract research organizations (CROs)/external vendors, providing oversight, guidance, and innovation in all aspects of statistical analysis.

This is a 6-month contract position with the potential for extension or transition to regular employment.

What You'll Do

• Study Leadership & Strategy:
  • Act as the lead trial statistician for assigned Phase II/III trials, ensuring timely delivery of high-quality, submission-ready analyses.
  • Provide strategic input into study designs, sample size calculations, protocol development, and implementation.
  • Oversee and perform work to author, maintain, and implement study-level statistical analysis plans.
  • Drive continuous alignment of analysis strategy with overall program milestones and regulatory objectives.
  • Translate clients’ needs into statistical practice.
• Data & Analysis Quality, Oversight & Delivery:
  • Collaborate with data management to ensure accuracy, consistency, and completeness of trial data.
  • Oversee and perform work to support operational reporting.
  • Coordinate and oversee interim and final analyses, ensuring data and analysis integrity.
  • Champion and help design and implement risk-based monitoring (RBQM).
  • Oversee and perform work involved in adoption of CDISC standards in analysis dataset creation.
• Cross-Functional & Regulatory Support:
  • Collaborate with Clinical Operations, Programming, Data Management, Medical Monitoring, and Safety throughout trial development.
  • Design and develop data-driven clinical trial surveillance reports.
  • Ensure data collection, completion, and cleaning occurs per expected timelines.
  • Collaborate in pharmacovigilance data management and regulatory reporting.
  • Deliver high-quality analytic results, datasets, listings, and reports for regulatory submissions.
  • Collaborate on clinical study reports, publications, and scientific presentations.
• CRO & Vendor Management:
  • Provide oversight, governance, and quality management of CRO analytic deliverables.
  • Review and approve vendor specifications and resulting deliverables.
  • Proactively identify and escalate risks, implementing corrective actions.

Qualifications

• Master’s degree in Statistics, Data Science, Mathematics, or a related field.
• Minimum of 6 years of progressive experience in clinical trial analysis.
• Proven track record of leading statistical aspects of Phase II/III clinical trials.
• Deep understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements.
• Strong leadership and project management skills.
• Exceptional problem-solving and analytical ability.
• Skilled communicator, able to influence and collaborate across teams.
• Vendor/CRO oversight experience.
• Technical proficiency in R; additional proficiency in SAS, Python, or other data programming preferred.
• Demonstrated ability to work independently and drive outcomes.

Benefits

• Competitive base salary.
• Generous paid time off policy.
• Merit-based annual increases and bonus opportunities.
• Robust recognition program.
• Competitive range of insurance plans (health, dental, life, disability).
• Access to a retirement savings program (401(k) plan).
• Paid parental leave for all parents.
• Financial assistance with adoption expenses or infertility treatments.
• Financial reimbursement for education and developmental opportunities.
• Employee assistance program.
• Numerous offerings to support a healthy work-life balance.

Hiring Salary Range

$125,000 - $153,000