Principal Biostatistician

A company is looking for a Principal Biostatistician FSP - Late Phase Oncology.

Key Responsibilities

Provide statistical leadership and expertise for clinical development projects and ensure alignment of objectives

Lead statistical teams, manage biostatisticians, and coordinate statistical aspects across clinical trials

Contribute to study protocols, write statistical analysis plans, and lead regulatory submissions and interactions

Required Qualifications

Ph.D. or MS in Statistics, Biostatistics, or a related discipline

At least 6 years of experience as a biostatistician in the Pharmaceutical / Biotechnology industry

Minimum 3 years of experience as a Lead Biostatistician for clinical development projects

Knowledge of international regulatory guidelines and experience with FDA submissions

Proficiency in SAS and CDISC standards