Senior/Principal Statistician Consultant - Phase III Oncology (Remote)
Core
Senior/Principal Biostatistician supporting Phase III oncology clinical trials, including study design, analysis, and regulatory submissions.
Role type
Senior/Principal Biostatistician (Oncology)
Builds
Clinical study deliverables (TFLs, ADaM specs, interim analyses, regulatory submissions)
Domain
Clinical Trials / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Phase III oncology trial experience, oncology endpoints (OS, PFS, ORR, DoR), time-to-event analysis, censoring rules, Kaplan-Meier, Cox Proportional Hazards, stratified log-rank tests, SAS programming, TFL/ADaM specifications, multi-study project management
Preferred skills
FDA/EMA regulatory submissions, IDMC/DMC activities, R programming, CRO/pharma/biotech environment experience
Technologies
SAS, R
Responsibilities
Provide statistical expertise and hands-on support for Phase III oncology clinical trials; Contribute to study design, statistical analysis, interpretation of results, and clinical study deliverables; Author, review, and provide input into TFL and ADaM specifications; Review statistical programming outputs and resolve discrepancies; Manage deliverables across multiple concurrent clinical studies; Support interim analyses and IDMC/DMC activities
Seniority
Principal, hands-on IC with strategy & mentorship
