Biostatistics Director — Oncology Biosimilars Strategy Lead

Amgen SA; United States; Hybrid; USD 180,000 - 270,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Time-off programs

Flexible work arrangements

Job summary

Amgen is seeking a Biostatistics Director to lead statistical strategy across multiple products and therapeutic areas from early to late-stage development. You will provide strategic input and oversee all statistical aspects of clinical development, ensuring rigorous design, analysis, and reporting.

The role requires a Doctorate or equivalent with extensive experience in regulatory submissions, leadership, and collaboration with global teams and CROs.

Qualifications

• Doctorate degree in Biostatistics with 4 years of Biostatistics experience
• Master’s degree with 8 years of Biostatistics experience
• Bachelor’s degree with 10 years of Biostatistics experience

Responsibilities

• Provide strategic statistical input for clinical development across early to late phases
• Review CSRs, SAPs, protocols and regulatory documents
• Develop and oversee statistical strategy, study design and analyses
• Mentor internal statisticians and CRO partners to ensure timelines and quality
• Represent statistics in regulatory meetings and submissions

Skills

Statistical leadership

Regulatory submissions

Communication & presentation

Adaptive designs

Team leadership

Drug development knowledge

Clinical development strategy

Statistical methodology

Education

Doctorate in Biostatistics

Master’s in Biostatistics

Bachelor’s in Biostatistics

Job description

Amgen is seeking a Biostatistics Director to lead statistical strategy across multiple products and therapeutic areas from early to late-stage development. You will provide strategic input and oversee all statistical aspects of clinical development, ensuring rigorous design, analysis, and reporting.

The role requires a Doctorate or equivalent with extensive experience in regulatory submissions, leadership, and collaboration with global teams and CROs.