Clinical Trial Statistician

Why RTI

RTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approach-one that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the world's most challenging problems.

We believe in the promise of science and technical solutions, and we push ourselves every day to deliver on that promise for the good of people, communities, and businesses in the US and around the world. If you are looking for the opportunity to make a real difference, RTI is the place for you.

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

• Act as the lead trial statistician and provide the associated expertise for assigned Phase II/III trials, ensuring timely delivery of high‑quality, submission‑ready analyses.
• In collaboration with trial coordinators, investigators, and data managers, provide strategic input into study designs, sample size calculations, protocol development and implementation, data collection strategies, and analytic plans to optimize trial quality and efficiency.
• Ability to oversee and perform work to author, maintain, and implement study‑level statistical analysis plans, analysis dataset specifications and TLF shells, randomization approaches, analysis and reporting programs, and other analysis‑related deliverables and activities.
• Drive continuous alignment of analysis strategy with overall program milestones and regulatory objectives.
• Ability to translate clients' needs into statistical practice.

• Collaborates with data management to ensure accuracy, consistency, and completeness of trial data through ongoing review, cleaning, and reconciliation (SAE, labs, imaging, biomarkers, PK, PRO/ePRO, etc.).
• Ability to oversee and perform work to support operational reporting (e.g., sponsor/leadership status reports, DSMB reports, operational support reports).
• Coordinate and oversee interim and final analyses, collaborating on timing of database snapshots and ensuring data and analysis integrity for study monitoring, publications, and regulatory filings.
• Champion and help design and implement risk‑based monitoring (RBQM) and centralized data review.
• Ability to oversee and perform work involved in adoption of CDISC standards (SDTM/ADaM) in analysis dataset creation.

• Routinely collaborate and liaise with Clinical Operations, Programming, Data Management, Medical Monitoring, and Safety throughout…