Lead Contract Clinical Trial Statistician (Phase II/III)

RTI International; North Carolina; On-site; USD 125,000 - 153,000; Part time

Job summary

RTI International in San Francisco, CA is seeking a Contract Senior Clinical Trial Statistician (Sr. Stat) to oversee end-to-end analysis across Phase II/III trials on a 6-month contract.

You will lead statistical analyses, validate data, ensure GCP compliance, collaborate with CROs, and contribute to regulatory submissions; strong expertise in CDISC SDTM/ADaM, R, SAS, and Python is required.

Qualifications

• Master's degree in Statistics, Data Science, Mathematics, or a related field with 6+ years of clinical trial analysis experience.
• Deep understanding of ICH-GCP, FDA/EMA regulatory requirements, CDISC standards (SDTM/ADaM).
• Strong leadership, project management, and communication skills; ability to work independently.

Responsibilities

• Act as lead trial statistician for Phase II/III trials, ensuring timely, submission-ready analyses.
• Collaborate with trial teams to design studies, calculate sample sizes, and develop SAPs.
• Oversee analysis datasets, SDTM/ADaM implementation, and reporting programs.
• Coordinate CRO/vendor oversight and ensure data integrity for regulatory submissions.

Skills

Leadership

Project management

Cross-functional collaboration

Regulatory knowledge

Data integrity

Statistical analysis

Education

Master's degree in Statistics or related field

Tools

R

SAS

Python

Job description

RTI International in San Francisco, CA is seeking a Contract Senior Clinical Trial Statistician (Sr. Stat) to oversee end-to-end analysis across Phase II/III trials on a 6-month contract.

You will lead statistical analyses, validate data, ensure GCP compliance, collaborate with CROs, and contribute to regulatory submissions; strong expertise in CDISC SDTM/ADaM, R, SAS, and Python is required.