Tech Stack

Description

You will serve as a lead statistician for clinical late-stage programs and a subject matter expert in biostatistics, providing statistical leadership and contributing to clinical development plans for oncology therapies. Collaborate on cross-functional teams to design studies, develop protocols and analysis plans, support regulatory submissions, and drive department initiatives.

Requirements

• PhD or MS in Statistics/Biostatistics with 10+ years (PhD) or 14+ years (MS) pharma/biotech experience
• Extensive experience in phase 3 oncology trial design and conduct
• Solid knowledge of ICH and regulatory requirements for biostatistics
• Excellent communication and project management skills
• Proficiency in SAS and/or R

Responsibilities

• Lead statistical support for clinical development plans and late-stage oncology programs
• Provide statistical input to study design, protocol development, analysis plans, and specifications
• Plan and coordinate with independent DMC for periodic reviews
• Collaborate with data management, clinical operations, and statistical programming
• Support regulatory submissions and publications, ensuring data accuracy and consistency