Senior Director, Biostatistics – Biosimilars Leader

Amgen; Washington (District of Columbia); On-site; USD 190,000 - 240,000; Full time

Job summary

Amgen in Washington DC seeks a Senior Director, Biostatistics to provide strategic statistical input across biosimilar development. You will lead a team of biostatisticians, manage CRO relationships, and shape regulatory submissions with innovative study designs.

You will champion statistical excellence, oversee protocols and analysis plans, and guide colleagues in method development and reporting. A PhD/MD in Biostatistics with senior leadership experience is preferred.

Qualifications

• PhD or Master with leadership in biosimilar/biotech environments.
• Strong background in biostatistics and clinical trial design.
• Experience leading teams and managing CRO relationships.

Responsibilities

• Oversee protocols, SAPs, clinical study reports, and regulatory submissions.
• Provide strategic statistical input across biosimilar development.
• Lead and develop the biosimilar biostatistics team and manage CROs.

Skills

Leadership

Biostatistics

Regulatory submissions

Clinical statistics

People management

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

BSc in Statistics

Tools

SAS

R

Job description

Amgen in Washington DC seeks a Senior Director, Biostatistics to provide strategic statistical input across biosimilar development. You will lead a team of biostatisticians, manage CRO relationships, and shape regulatory submissions with innovative study designs.

You will champion statistical excellence, oversee protocols and analysis plans, and guide colleagues in method development and reporting. A PhD/MD in Biostatistics with senior leadership experience is preferred.