Senior Biostatistics Manager, Biosimilars – Remote

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 154,000 - 208,000; Full time

Benefits offered by this job

Competitive benefits

Flexible work models

Career development opportunities

Job summary

Amgen Inc. is seeking a Biostatistics Senior Manager for Biosimilars US-Remote. You will lead statistical activities across studies, ensure regulatory-grade analyses, and influence development strategy with CRO partners.

This role demands advanced degrees, extensive biostatistics experience, and strong collaboration with cross-functional teams, with responsibilities spanning protocols, SAPs, TLGs, and regulatory submissions.

Qualifications

• Doctorate or Master’s with Biostatistics experience as a baseline requirement.
• Strong leadership and collaboration skills across global teams.
• Experience contributing to regulatory submissions and safety/effectiveness documentation.

Responsibilities

• Lead statistical analyses for complex studies and CRO collaboration.
• Develop and defend statistical approaches across protocols, SAPs, and CSRs.
• Provide statistical guidance during regulatory submissions and publications.

Skills

Leadership

Statistical analysis

Regulatory submissions input

Cross-functional collaboration

Education

Doctorate degree in Biostatistics

Master’s degree in Biostatistics or statistics

Bachelor’s degree in Biostatistics or related

Job description

Amgen Inc. is seeking a Biostatistics Senior Manager for Biosimilars US-Remote. You will lead statistical activities across studies, ensure regulatory-grade analyses, and influence development strategy with CRO partners.

This role demands advanced degrees, extensive biostatistics experience, and strong collaboration with cross-functional teams, with responsibilities spanning protocols, SAPs, TLGs, and regulatory submissions.