Job Overview
Location
United States - Remote
Job Type
Full-time
Category
Data Science
Date Posted
June 6, 2026
Full Job Description
đź“‹ Description
- • Lead study-level statistical deliverables with substantial independence, ensuring high-quality outputs that meet CfDA and regulatory expectations.
- • Provide strategic statistical guidance to clinical development, reimbursement, and medical affairs teams to inform study design and analysis decisions.
- • Plan and execute statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs), ensuring scientific rigor and regulatory compliance.
- • Implement and support standardized statistical methodologies, technical quality controls, and consistent approaches across study design and analysis.
- • Stay current with advancements in statistical methods for drug development, including innovative trial designs, and align them with Amgen’s statistical policies and strategies.
- • Oversee key study documentation including statistical analysis plans, randomization specifications, tables, figures, listings, submission data files, and other critical study-related deliverables.
- • Collaborate cross-functionally to deliver robust, valid, and scientifically sound analysis results in Tables, Figures, and Listings (TFLs), Flash Memos, CSRs, clinical publications, and regulatory communications.
- • Serve as the Global Biostatistics (GBS) lead on Clinical Study Team leadership teams, executing trials per protocol, conducting risk assessments, and ensuring alignment between data collection and study objectives.
- • Contribute to regulatory filings, reimbursement submissions, clinical publications, and other product-related communications with statistical expertise.
- • Provide statistical consultancy, training, and advice across Amgen to enhance statistical capability and consistency.
- • Manage and oversee contributions from FSP (Functional Service Provider) statisticians, ensuring quality and adherence to standards.
- • Maintain and update the statistics sections of the Trial Master File (TMF) to ensure regulatory readiness.
- • Opportunity to manage staff, including external contractors and consultants.
- • Opportunity to serve as a product regional lead, providing regional statistical leadership and alignment.
- • Contribute to process improvement initiatives aimed at enhancing operational efficiency and statistical workflow.
🎯 Requirements
- • Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- • Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- • Bachelor’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- • Experience leading statistical contributions to regulatory and reimbursement submissions
- • Experience working in a globally dispersed team environment with cross-cultural partners
- • Knowledge of life cycle drug development (pre-clinical, clinical, and post-marketing)
🏖️ Benefits
- • Comprehensive employee benefits package including retirement and savings plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
- • Discretionary annual bonus program or sales-based incentive plan for field sales representatives
- • Stock-based long-term incentives
- • Award-winning time-off plans
- • Flexible work models where possible
- • Career development opportunities
Skills & Technologies
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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