Senior Biostatistics Director, Oncology Biosimilars

BioSpace; Washington (District of Columbia); Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health and welfare plans

Discretionary annual bonus

Stock-based incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen seeks a Biostatistics Director to provide strategic statistical input across early to late-phase clinical development for multiple products. You will lead and mentor statistical staff, shape development plans, and drive methodological excellence.

The role requires advanced biostatistics expertise, strong collaboration with global teams, and a track record in regulatory discussions and publications. Amgen offers comprehensive benefits and flexible work options.

Qualifications

• Doctorate degree and 4 years of Biostatistics experience.
• Master's degree and 8 years of Biostatistics experience.
• Bachelor's degree and 10 years of Biostatistics experience.

Responsibilities

• Develops and maintains successful application of statistical excellence in design, analysis, and reporting across biosimilar development and multiple products.
• Reviews product and study documents including clinical development plans, protocols, SAPs, CSRs, submissions, and regulatory correspondence.
• Responsible for hiring, allocation, management, and development of internal statistical staff and for goals, budgets, and resource plans.
• Developing and executing statistical strategy for clinical programs ensuring standards and high-quality analysis and presentation of results.
• Providing statistical input into regulatory strategies, submissions, and scientific reports.

Skills

Biostatistics

Statistical leadership

Regulatory submissions

Clinical development

Team leadership

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

Amgen seeks a Biostatistics Director to provide strategic statistical input across early to late-phase clinical development for multiple products. You will lead and mentor statistical staff, shape development plans, and drive methodological excellence.

The role requires advanced biostatistics expertise, strong collaboration with global teams, and a track record in regulatory discussions and publications. Amgen offers comprehensive benefits and flexible work options.