Job Overview
Location
United States - Remote
Job Type
Full-time
Category
Data Science
Date Posted
June 18, 2026
Full Job Description
đź“‹ Description
- • Lead statistical strategy and execution for biosimilar products, ensuring all statistical aspects of clinical documentation meet regulatory standards and are scientifically sound.
- • Design, oversee, and validate Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data Files (SDFs), Clinical Study Reports (CSRs), and other key clinical study documents in collaboration with CROs.
- • Provide statistical input for regulatory submissions, including Clinical Summaries of Safety (CSS), Clinical Summaries of Efficacy (CSE), Clinical Overviews (COs), and other regulatory communications.
- • Manage and supervise statistical work performed by full-service CROs, ensuring quality, consistency, and adherence to Amgen’s standards and industry best practices.
- • Conduct complex statistical analyses across multiple studies and exploratory datasets, translating results into actionable insights and recommendations for cross-functional teams.
- • Act as the primary statistical representative on multidisciplinary project teams, contributing to protocol design, case report form development, and data collection strategies.
- • Proactively identify and communicate resource, timeline, or quality risks that could impact study deliverables, both within Biostatistics and across functions.
- • Apply deep knowledge of biosimilar development, including non-inferiority and equivalence trial designs, regulatory guidelines, and industry standards.
- • Contribute to scientific advancement by publishing applied research in peer-reviewed journals and presenting statistical methodologies at internal or external scientific meetings.
- • Participate in the development and review of CRO policies, SOPs, and process maps to enhance operational efficiency and alignment with Amgen’s standards.
- • Ensure full compliance with Amgen’s SOPs, policies, and regulatory requirements specific to biosimilar drug development.
- • Deliver clear, compelling presentations of statistical findings to internal stakeholders (study teams, product teams) and external audiences (regulatory agencies, steering committees, investigator meetings).
- • Maintain current expertise in evolving statistical methodologies, including adaptive designs such as group sequential, Bayesian adaptive, and combined phase 1/2 or phase 2/3 trial structures.
- • Demonstrate leadership in independently managing the design, analysis, and reporting of at least one complex or multiple less complex clinical studies within the pharmaceutical or biotechnology industry.
- • Collaborate effectively within global teams and with external partners to drive operational excellence and timely delivery of statistical outputs.
- • Communicate statistical concepts and results with clarity and precision, both verbally and in writing, to technical and non-technical audiences.
🎯 Requirements
- • Doctorate degree and 2 years of Biostatistics experience OR Master’s degree and 6 years of Biostatistics experience OR Bachelor’s degree and 8 years of Biostatistics experience
- • Experience in biosimilar development, including non-inferiority or equivalence trials
- • Statistical contributions to regulatory submissions
- • Independent leadership in the design, analysis, and reporting of complex clinical studies
- • Demonstrated ability to present and defend statistical findings to internal and external audiences
- • Experience working with full-service CROs in a pharmaceutical or biotechnology setting
🏖️ Benefits
- • Comprehensive employee benefits package including medical, dental, and vision coverage
- • Retirement and Savings Plan with generous company contributions
- • Discretionary annual bonus program
- • Stock-based long-term incentives
- • Award-winning time-off plans
- • Flexible work models where possible
Skills & Technologies
See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.
About Amgen Inc.
Amgen Inc. is a global biotechnology company headquartered in Thousand Oaks, California. Founded in 1980, it discovers, develops, manufactures, and delivers human therapeutics targeting cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Using advanced recombinant DNA and molecular biology techniques, Amgen produces biologic medicines such as Neulasta, Enbrel, and Prolia. The company operates R&D, manufacturing, and distribution facilities worldwide, investing heavily in genomic research to identify novel drug targets. Amgen also partners with academic institutions and smaller biotechs to expand its pipeline, aiming to transform breakthrough science into therapies that significantly improve patients’ lives.
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