Senior/Principal Statistician Consultant – TA, Oncology

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

📋 Description

• Deliver statistical expertise and operational assistance for oncology clinical trial initiatives.

• Aid in statistical evaluations of oncology endpoints, encompassing time-to-event and response-based measures.

• Execute event forecasts to approximate the timing of upcoming event-driven analyses.

• Assess and provide input on SDTM and ADaM specifications, tables, listings, figures, statistical analysis plans, protocol modifications, and pertinent study documentation.

• Perform routine reviews of study data to detect inconsistencies, missing information, or other issues that may impact analysis or interpretation.

• Confirm the accuracy of statistical outputs and document reproducibility and quality assurance.

• Work collaboratively with internal study teams, programming units, and relevant functional collaborators.

⛳️ Requirements

• Proven experience in supporting Phase 2 and Phase 3 oncology clinical trials, including event-driven and response-based endpoints.

• Background in reviewing clinical trial data to spot inconsistencies, missing information, unexpected trends, or issues requiring attention.

• Capability to document review findings, assumptions, queries, and follow-up items clearly, as well as track issues until resolution.

• Familiarity with CDISC standards, including SDTM and ADaM.

• Excellent written communication skills.

• Strong analytical abilities and a systematic approach to data review, statistical output assessment, and issue detection.

• Ability to collaborate effectively with study teams, programming teams, and relevant functional partners.

• Comprehensive understanding of statistical analysis methodologies and experimental design principles.

• Proficient in statistical programming and data processing tools, such as SAS and/or R.

• PhD or equivalent in statistics, biostatistics, or a related field with a minimum of 3 years of relevant professional experience; or a Master’s degree with at least 6 years of relevant experience.

• Availability during standard U.S. business hours, typically from 9:00 a.m. to 3:00 p.m. Eastern Time.

🏝️ Benefits

• Opportunities for professional growth.

• Ongoing training and development.

• A workplace that prioritizes equal opportunity and diversity.