[Hiring] Contract Clinical Trial Statistician @Research Triangle Institute

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 role plays a critical part in accelerating timelines, supporting regulated clinical trials, and driving the overall success of clinical development programs. This is a 6-month contract position with the potential for extension or transition to regular employment.

Qualifications

• Master’s degree in Statistics, Data Science, Mathematics, or a related field.
• Minimum of 6 years of progressive experience in clinical trial analysis within a biotech, pharmaceutical, or CRO environment for trials conducted under INDs or equivalent experience.
• Proven track record of leading statistical aspects of Phase II/III clinical trials through development, database lock, and reporting/submission.
• Deep understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements.
• Expertise in design/analysis, CDISC standards (SDTM, ADaM), and associated electronic data submission to regulatory agencies.
• Strong leadership and project management skills.
• Exceptional problem-solving and analytical ability.
• Skilled communicator, able to influence and collaborate across cross-functional teams and with external partners.
• Able to lead meetings with both internal and external collaborators.
• Vendor/CRO oversight experience.
• Technical proficiency in R is required; additional proficiency in SAS, Python, or other data programming preferred.
• Demonstrated ability to work independently and drive outcomes with minimal supervision.

Requirements

• Act as the lead trial statistician for assigned Phase II/III trials.
• 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.
• Collaborate with data management to ensure accuracy, consistency, and completeness of trial data.
• Coordinate and oversee interim and final analyses.
• Champion and help design and implement risk-based monitoring (RBQM) and centralized data review.
• Collaborate with Clinical Operations, Programming, Data Management, Medical Monitoring, and Safety throughout trial development.
• Deliver high-quality analytic results, datasets, listings, and reports to support regulatory submissions.
• Provide oversight, governance, and quality management of CRO analytic deliverables.

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, short-term and long-term disability).
• Access to a retirement savings program such as a 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 other offerings to support a healthy work-life balance.

Company Description

RTI International is an independent nonprofit research institute dedicated to improving the human condition.