Principal Biostatistician Consultant- Remote in US (Oncology)
Core
Provide statistical leadership for oncology clinical development programs, supporting Phase I–III trials and regulatory submissions.
Role type
Principal Biostatistician (Oncology)
Builds
Clinical study reports, statistical analysis plans, and regulatory submissions for oncology trials.
Domain
Biopharmaceuticals / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Survival analysis, time-to-event endpoints, complex oncology study designs, CDISC standards (SDTM/ADaM), regulatory submission support, SAS, R, sample size calculations
Preferred skills
Adaptive designs, Bayesian methods, immuno-oncology experience, hematology oncology experience
Technologies
SAS, R
Responsibilities
Lead development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs); Design and review statistical methodologies for efficacy and safety analyses; Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards; Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs; Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries; Provide strategic input on study design, endpoint selection, and sample size calculations; Mentor junior statisticians and provide technical guidance.
Seniority
Principal, hands-on IC with mentorship
