Senior/Principal Statistician Consultant – Phase III Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide statistical expertise and practical support for Phase III oncology clinical trials.

• Contribute to study design, statistical analysis, interpretation of results, and clinical study deliverables.

• Implement censoring techniques and conduct time-to-event analyses.

• Perform and interpret Kaplan-Meier analysis, Cox Proportional Hazards models, and stratified log-rank tests.

• Author, review, and offer insights into TFL and ADaM specifications in collaboration with Statistical Programming.

• Examine statistical programming outputs, detect discrepancies, and work with programmers to address issues.

• Utilize SAS to review outputs and execute data and analysis verifications.

• Oversee deliverables across various concurrent clinical studies.

• Collaborate with Biostatistics, Statistical Programming, Data Management, Clinical, Regulatory, and other cross-functional teams.

• Assist with interim analyses and IDMC/DMC activities, including the preparation and review of DMC outputs.

⛳️ Requirements

• Advanced degree (MS, PhD, or equivalent) in Statistics, Biostatistics, or a related quantitative discipline.

• Direct, hands-on experience supporting at least one Phase III oncology clinical trial.

• Comprehensive understanding of oncology clinical trial endpoints, including OS, PFS, ORR, and DoR.

• In-depth knowledge of censoring rules and time-to-event analysis.

• Practical experience with Kaplan-Meier, Cox Proportional Hazards, and stratified log-rank methods.

• Proficient SAS programming skills.

• Experience in authoring or reviewing TFL and ADaM specifications.

• Capability to identify and resolve discrepancies in analysis outputs.

• Ability to work independently with minimal supervision.

• Skill in managing deliverables across multiple concurrent clinical trials.

• Excellent written and verbal communication abilities.

• Experience supporting FDA and/or EMA regulatory submissions is preferred.

• Familiarity with IDMC/DMC activities and interim analyses is preferred.

• Experience with R programming is an advantage.

• Background working in a CRO, pharmaceutical, or biotechnology setting is preferred.

🏝️ Benefits

• Opportunities for professional growth.

• Ongoing training and development.

• A workplace focused on equal opportunity and diversity.