Biostatistics Manager, Biosimilar Development - Remote

Overview

The Biostatistics Manager in Biosimilar Development at Amgen coordinates and performs statistical analysis and reporting for clinical studies, ensuring compliance with regulatory standards and contributing to scientific research.

In Short

• Coordinate statistical design and analysis of clinical studies.
• Review and ensure quality of study documentation.
• Provide statistical input for publications and presentations.
• Collaborate with CROs and multidisciplinary teams.
• Anticipate and communicate resource issues affecting timelines.
• Stay updated on statistical developments in drug development.
• Participate in the review of CRO policies and SOPs.
• Contribute to process improvement and operational efficiency.
• Adhere to Amgen policies and standards.
• Support career development and work/life balance initiatives.

Requirements

• Doctorate degree or relevant statistical experience.
• Master’s degree in Statistics/Biostatistics preferred.
• Ability to provide strategic input on study design.
• Effective communication skills, both written and oral.
• Experience in the pharmaceutical industry or medical research.
• Ability to work within a global team.
• Strong understanding of regulatory guidelines.
• Experience with statistical analysis tools.

Benefits

• Comprehensive employee benefits package.
• Retirement and savings plans with company contributions.
• Flexible work models, including remote work arrangements.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Career development opportunities.