Principal Biostatistician
Core
Lead design, analysis, and interpretation of clinical studies for rare disease and oncology trials, supporting IND/NDA/BLA submissions.
Role type
Principal Biostatistician (Lead IC)
Builds
Clinical study statistical outputs, analysis plans, and regulatory submission reports
Domain
Clinical research, rare disease, oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Biostatistics, SAS, survival analysis, logistic regression, mixed models, ICH guidelines, trial design, statistical programming oversight, project management
Preferred skills
Contract Research Organization experience, advanced statistical methods, mentoring
Technologies
SAS
Responsibilities
Lead biostatistics activities for complex clinical programs; review and develop statistical analysis plans and protocols; oversee statistical programming output; write study reports and summaries; mentor junior statisticians; represent the function in audits and cross-functional meetings.
Seniority
Principal, hands-on IC with leadership responsibilities