Biostatistics Director - Biosimilars & Strategy

BioSpace; Washington (District of Columbia); On-site; USD 230,000 - 320,000; Full time

Job summary

Amgen in the United States seeks a Senior Director, Biostatistics to provide strategic statistical input and oversee all statistical aspects of biosimilar development. You will lead a team of biosimilars biostatisticians and manage CROs, advancing methodologies and study designs for regulatory submissions.

Responsibilities include ensuring quality, contributing to regulatory strategies, and mentoring staff while collaborating with cross-functional teams on global development programs.

Qualifications

• Doctorate/master’s level training in statistics/biostatistics with leadership experience.
• Experience leading teams on biosimilar or pharmaceutical development projects.
• Strong track record in statistical strategy, analysis plans, and regulatory communications.

Responsibilities

• Provide strategic statistical input and oversee all statistical aspects of biosimilar development.
• Lead and develop the biosimilars biostatistics team and manage CRO relationships.
• Drive statistical methodology, study design, and regulatory submissions for approval processes.
• Oversee adherence to quality standards and contribute to budgets and resourcing.

Skills

Statistical leadership

Regulatory submissions

People management

Biostatistics expertise

Education

Doctorate degree

Masters degree

Bachelor's degree

Job description

Amgen in the United States seeks a Senior Director, Biostatistics to provide strategic statistical input and oversee all statistical aspects of biosimilar development. You will lead a team of biosimilars biostatisticians and manage CROs, advancing methodologies and study designs for regulatory submissions.

Responsibilities include ensuring quality, contributing to regulatory strategies, and mentoring staff while collaborating with cross-functional teams on global development programs.