Senior Director, Biostatistics — Biosimilars Strategy

Amgen SA; United States; Remote; USD 210,000 - 300,000; Full time

Job summary

Amgen is seeking a Senior Director of Biostatistics to lead statistical strategy and oversight for biosimilar development across products. You will manage a team of biostatisticians, collaborate with CROs, and drive innovative methodologies in regulatory submissions.

The role requires extensive leadership experience, strong regulatory acumen, and a track record in global development programs. Join Amgen’s mission to serve patients and advance science in a collaborative environment.

Qualifications

• PhD or Master's with extensive senior leadership in biostatistics.
• Experience leading teams and managing resources.
• Strong background in biosimilar development and regulatory interactions.
• Proven ability to influence regulatory submissions and scientific strategy.
• Experience working with CROs and global teams.

Responsibilities

• Provide oversight for statistical protocols, SAPs, and regulatory documents.
• Lead and develop biosimilar biostatistics teams and CRO partners.
• Contribute to statistical strategy and study designs across development programs.
• Represent statistical perspectives in regulatory meetings and communications.
• Guide staff development and drive process improvements across the function.

Skills

Senior Director Biostatistics

Leadership

Regulatory submissions

Biostatistics

CRO management

Education

Doctorate in Statistics/Biostatistics

Master’s degree in Statistics/Biostatistics

Bachelor’s degree

Job description

Amgen is seeking a Senior Director of Biostatistics to lead statistical strategy and oversight for biosimilar development across products. You will manage a team of biostatisticians, collaborate with CROs, and drive innovative methodologies in regulatory submissions.

The role requires extensive leadership experience, strong regulatory acumen, and a track record in global development programs. Join Amgen’s mission to serve patients and advance science in a collaborative environment.