Biostatistics Senior Manager, Biosimilars US - Remote

About the role

Amgen is hiring a Biostatistics Senior Manager for its Biosimilars US team, working remotely. The role leads a single large product and/or more complex studies and projects, ensures that statistical aspects of clinical documentation meet required standards, contributes to the development strategy and defends statistical approaches internally and externally.

Key responsibilities

• Implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Plan and execute statistical contributions to protocols, randomization specifications, SAPs, TLG shells, SDF specifications, protocol deviations, Flash Memos, CSRs and other communications, in close partnership with CROs in a full-service CRO model.
• Provide statistical inputs to clinical publications, CSSs, CSEs, COs and regulatory documents.
• Oversee statistical work performed by CROs and perform statistical analysis of multiple studies and exploratory analyses.
• Represent the Biostatistics function in multidisciplinary project meetings and collaborate with other functions, for example in case report form design and data collection.
• Anticipate and communicate resource and quality issues affecting deliverables or timelines.
• Review CRO policies, SOPs and process maps, and contribute to process improvement.
• Stay up to date with statistical developments in drug development and publish applied research and present methodology at internal or external meetings.

Required profile

• Basic: doctorate with 2 years of biostatistics experience, or master's with 6 years, or bachelor's with 8 years of biostatistics experience.
• Preferred: master's in statistics/biostatistics or another high-statistics subject with 8 years of post-graduate statistical experience in pharma or medical research, or a doctoral degree with 5 years of post-graduate statistical experience.
• Knowledge of biosimilar development, non-inferiority or equivalence trials, and statistical contributions to regulatory submissions.
• Experience leading the design, analysis and reporting of at least one complex or multiple less complex studies in industry, government or academia.
• Ability to defend statistical findings and work within a global team and with CRO partners.

Required skills

• Theoretical and applied statistics and regulatory guidelines on biosimilar development.
• Adaptive designs (group sequential, treatment-arm selection, Bayesian adaptive) and combined phase 1/2 or 2/3 designs.
• Effective written and oral communication.

What we offer

• Annual salary range posted for the U.S. (excluding Puerto Rico).
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and flexible work models where possible.