Biostatistics Senior Manager, Biosimilars US- Remote

Amgen is seeking a Biostatistics Senior Manager to lead statistical activities for biosimilar development.

• Implements, oversees, and supports standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis.
• Plans and executes statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, and other key study documentation in close partnership with CROs.
• Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
• Oversees statistical work performed by CROs within a full-service CRO model.
• Performs statistical analysis of multiple studies/projects and subsequent exploratory analyses, making sound conclusions and recommendations.
• Represents the Biostatistics function and participates in multidisciplinary project team meetings, collaborating closely with other functional team members and incorporating cross‑functional knowledge to provide sound statistical guidance.
• Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines.
• Stays abreast of the latest developments in statistics for drug development and contributes to scientific advances through research publications and presentations at scientific meetings.
• Participates in the review of CRO policies, SOPs, and controlled documents, contributing to process improvement and operational efficiency.
• Adheres to all Amgen policies, SOPs, and other applicable standards related to biosimilar development.

Basic Qualifications

• Doctorate degree and 2 years of Biostatistics experience
• Master’s degree and 6 years of Biostatistics experience
• Bachelor’s degree and 8 years of Biostatistics experience

Preferred Qualifications

• Master’s or Doctoral degree in Statistics/Biostatistics (or related field with high statistical content) and 8 or 5 years of post‑graduate statistical experience in the pharmaceutical industry or medical research.
• Knowledge/experience of biosimilar development, non‑inferiority or equivalence trials.
• Experience with regulatory submissions and statistical methodologies related to adaptive designs (e.g., group sequential design, Bayesian adaptive design, combined phase 1/2 or phase 2/3 designs).
• Independent leadership of the design, analysis and reporting of at least one complex study or multiple less‑complex studies/projects in an industry, government, or academic setting.
• Demonstrated ability to provide strategic and statistical input to meet project needs, regulatory and scientific requirements.
• Demonstrated ability to present results and defend statistical findings to internal and external audiences (e.g., investigator meetings, steering committees, regulatory meetings).
• Demonstrated ability to work within a global team and with CRO partners to ensure operational excellence and efficiencies.
• Excellent written and oral communication skills.

• Competitive salary and Total Rewards Plan including health, dental, vision, life, and disability insurance.
• Retirement and Savings Plan with generous company contributions.
• Flexible spending accounts.
• Discretionary annual bonus program (and sales‑based incentive plan for field sales representatives).
• Stock‑based long‑term incentives.
• Time‑off plans and flexible work models where possible.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $ – $ USD.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.