Description

You will provide statistical leadership for oncology clinical development programs, supporting Phase I–III trials and regulatory submissions while collaborating with cross-functional teams.

Requirements

• Experience as a Principal Biostatistician providing statistical leadership for oncology programs
• Expertise in developing SAPs, protocols, and CSRs
• Knowledge of CDISC standards (SDTM/ADaM) and TLFs
• Experience with regulatory submissions and interactions with FDA/EMA
• Ability to work independently and establish high-trust client relationships

Responsibilities

• Provide statistical leadership for oncology clinical trials across Phase I–III
• Lead development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs)
• Design and review statistical methodologies for efficacy and safety analyses
• Support interim analyses, DMC activities, and adaptive designs
• Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries