Biostatistics Manager

Responsibilities

• Provide statistical and data science expertise to support Centralized Statistical Monitoring (CSM) activities across multiple studies and therapeutic areas
• Develop and enhance statistical, machine learning, and AI-guided methodologies to strengthen signal detection and site-level risk assessment
• Perform detailed statistical review and quality control of CSM outputs, signals, and study-level metrics
• Collaborate with cross-functional partners in Clinical, Operations, Data Management, and RBQM to translate quality factors into scalable monitoring solutions
• Contribute to the validation, documentation, and controlled deployment of analytical methodologies within regulated environments
• Develop clear visualizations, dashboards, and analytical applications to enhance transparency of monitoring outputs

Requirements

• MSc or PhD in Statistics, Biostatistics, or a related field
• 8 years of industrial experience in a relevant field
• Experience in a regulated environment involving clinical trial data collection, storage, and quality

Preferred Qualifications

• Proficiency in statistical programming using R, SAS, or Python
• Demonstrated experience applying machine learning and advanced analytical methods in practice
• Clinical trial experience within a pharmaceutical or medical research environment
• Prior experience serving as a study statistician for clinical trials
• Experience working effectively in a globally dispersed team environment
• Strong technical writing skills and ability to produce reports or project descriptions

Benefits

• Comprehensive employee benefits package including medical, dental, and vision coverage
• Retirement and Savings Plan with company contributions
• Discretionary annual bonus program and stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models including remote work arrangements where possible

About the Company

Amgen is a biotechnology pioneer committed to unlocking the potential of biology for patients suffering from serious illnesses. By leveraging advanced human genetics and biologics manufacturing expertise, Amgen discovers and delivers innovative human therapeutics to improve health outcomes and lives worldwide.