Senior Biostatistics Lead – Oncology Biosimilars

Amgen; Washington (District of Columbia); Remote; USD 180,000 - 280,000; Full time

Job summary

Amgen seeks a Biostatistics Director to lead statistical strategy across early to late-phase clinical development for multiple products in oncology and other areas. You will provide strategic statistical input, oversee study design, analysis plans, and regulatory submissions, and mentor a team of statisticians.

In this role you will collaborate with clinical, translational, and regulatory partners, shape statistical methods, and ensure high-quality statistical deliverables that support product

Qualifications

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

Responsibilities

• Develops and implements statistical strategy for clinical development programs across multiple products and therapeutic areas.
• Reviews regulatory documents, protocols, SAPs, CSRs, and publication materials.
• Hires, mentors, and manages internal statistical staff and collaborates with CROs.

Skills

Biostatistics

Clinical development

Regulatory submissions

Data analysis

Leadership

Communication

Education

Doctorate degree in Biostatistics

Master’s degree

Bachelor’s degree

Job description

Amgen seeks a Biostatistics Director to lead statistical strategy across early to late-phase clinical development for multiple products in oncology and other areas. You will provide strategic statistical input, oversee study design, analysis plans, and regulatory submissions, and mentor a team of statisticians.

In this role you will collaborate with clinical, translational, and regulatory partners, shape statistical methods, and ensure high-quality statistical deliverables that support product