Lead Biostatistician

Position Overview

• Location Type: Remote, USA
• Employment Type: Full time
• Salary: (Salary not provided in the text) This role is a key member of the CorEvitas Biostatistical Team, responsible for leading statistical deliverables on high-profile drug safety projects. The Lead Biostatistician will collaborate with clients, scientific resources, clinical principal investigators, and project staff. The position focuses on studies evaluating drug safety, specifically within the areas of query work, pharmacovigilance (PV) work, and registry coordination.

Requirements

• Statistical expertise
• Experience with study design and analysis
• Ability to develop and disseminate analytic reports
• Collaboration skills with diverse teams (investigators, clients, etc.)
• Understanding of regulatory commitments (FDA, EMA)

Responsibilities

• Collaborate with investigators to develop study protocols and Statistical Analysis Plans (SAPs).
• Perform sample size and power calculations.
• Develop and disseminate final analytic reports to clients.
• Lead client-facing conversations regarding study design and statistical aspects of safety-related research.
• Contribute original research projects.

Company Information

• Company: Thermo Fisher Scientific
• Division: CorEvitas
• Mission: To enable our customers to make the world healthier, cleaner and safer.
• Focus Areas: Query work, pharmacovigilance (PV) work, and registry coordination.
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office

Additional Information

• The CorEvitas Biostatistics team specializes in generating data intelligence and clinical insights needed to bring safe and effective treatments to market.
• The role involves working on long-term post authorization safety studies (PASS) and supporting regulatory commitments.