Director, Biostatistics – Oncology Biosimilars

Amgen; United States; Remote; USD 180,000 - 250,000; Full time

Job summary

Amgen is seeking a Biostatistics Director to provide strategic statistical leadership across clinical development programs. You will influence design, analysis, and regulatory submissions while guiding a team of statisticians and coordinating with CROs.

The role requires advanced degree in biostatistics with extensive experience in pharmaceutical development, strong communication, and a track record of innovative methodological leadership.

Qualifications

• PhD or equivalent in Biostatistics with extensive post-graduate experience.
• Advanced degree required for senior leadership in biotechnology.
• Strong knowledge of statistical design, analysis, and regulatory science.

Responsibilities

• Provide strategic statistical input across multiple products and therapeutic areas.
• Develop and maintain statistical excellence in design, analysis, and reporting for biosimilar development.
• Review regulatory documents, study protocols, SAPs, CSRs, and submissions.
• Hire, develop, and mentor internal statisticians and manage CROs; oversee budgets and resources.
• Develop statistical strategy aligned with regulatory expectations and product development plans.
• Represent statistics in regulatory meetings and with key opinion leaders; ensure high-quality outputs.

Skills

Statistical leadership

Regulatory submissions

Effective communication

Adaptive designs

Innovation in methods

Education

Doctorate degree in Biostatistics or related field

Master's degree in Biostatistics or related field

Bachelor's degree in a quantitative field

Job description

Amgen is seeking a Biostatistics Director to provide strategic statistical leadership across clinical development programs. You will influence design, analysis, and regulatory submissions while guiding a team of statisticians and coordinating with CROs.

The role requires advanced degree in biostatistics with extensive experience in pharmaceutical development, strong communication, and a track record of innovative methodological leadership.