Director / Senior Biostatistics - Remote

Overview

The Director / Senior Biostatistics will serve as the project lead statistician responsible for statistical activities at study level and compound level, including protocol development, study design, statistical data analysis, regulatory submissions, publications, and presentations at Nuvalent.

In Short

• Lead the development of statistical sections of clinical study protocols and analysis plans.
• Provide strategic input to optimize trial designs.
• Oversee CRO statistical activities and manage contractor statisticians.
• Collaborate with internal and external team members on projects.
• Contribute to regulatory submissions and biostatistics SOPs.
• Support audit and inspection readiness activities.
• Maintain competencies in statistical methodology and trial designs.

Requirements

• Minimum of MS required (Ph.D. preferred) in Statistics or related fields.
• 12+ years of experience in drug development in a CRO or pharma/biotech company.
• Oncology experience is strongly preferred.
• Regulatory NDA/BLA submission experience is preferred.
• Hands-on experience with SAS programming.
• Experience managing CROs and contractors.
• Excellent project management skills.

Benefits

• Equal employment opportunities.
• Work with experienced scientists and industry veterans.
• Contribute to innovative drug development.