Senior Manager, Biostatistics

About the role

We're seeking a Senior Manager, Biostatistics to join our Biometrics team. Reporting to the Senior Director, Biostatistics, you'll provide statistical expertise for clinical trials in development. Key responsibilities include input into protocol development, statistical analysis, and collaboration with cross-functional teams.

Responsibilities

• Provide statistical input into protocol development, statistical analysis plans, and other key trial documents
• Support study setup activities including randomization, sample size justification, and selection of appropriate analysis methods
• Perform or oversee statistical analyses of clinical trial data to ensure timely and accurate reporting
• Contribute to the preparation of clinical study reports, regulatory submissions, and responses to health authority queries
• Collaborate with cross-functional teams (clinical, programming, data management, regulatory) to ensure statistical integrity and compliance
• Review and provide feedback on deliverables from CRO partners or internal programming teams
• Aid in the development and implementation of departmental standards and infrastructure initiatives
• Stay current with relevant statistical methodology and regulatory guidance, and apply as appropriate

Requirements

You have a PhD in Statistics/Biostatistics with 2+ years of relevant pharmaceutical experience. You must demonstrate strong knowledge of statistical concepts and techniques commonly used in clinical development, familiarity with regulatory requirements and guidelines, comprehensive understanding of advanced statistical concepts, excellent project management, interpersonal, and communication skills, and ability to work independently and collaborate effectively.