Centralized Statistical Monitoring, Director

Let’s do this. Let’s change the world. In this vital role you will provide strategic, statistical, technical, operational, and business leadership for Centralized Statistical Monitoring (CSM). The role is accountable for the CSM analysis system, signal framework, statistical methodology, team leadership, cross-functional delivery, and continued evolution of CSM as part of Amgen’s broader Risk-Based Quality Management (RBQM) and study quality oversight strategy.

The successful candidate will lead CSM capability development across a growing clinical portfolio, ensuring that CSM remains scientifically rigorous, scalable, inspection-ready, and aligned with portfolio, regulatory, study team, and business needs. The role may also support related RBQM analytical needs, including Quality Tolerance Limit (QTL) approaches, where aligned with CSM scope and portfolio priorities.

Accountabilities

• Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows.

• Lead the strategy, roadmap, operating model, and continued evolution of the CSM capability in partnership with the Head of CSM / CfDA Safety and cross-functional stakeholders.

• Provide leadership and accountability for the CSM Statistics team and statistical deliverables supporting the CSM capability.

• Advance conventional and innovative CSM methodology to support RBQM, Quality by Design, data quality, data integrity, and clinical study quality oversight.

• Prioritize CSM system enhancements, signal development, automation opportunities, and related RBQM analytical needs, including QTL approaches where aligned with CSM scope and portfolio priorities.

• Lead governance, documentation, inspection readiness, lifecycle management, and long-term sustainability of the CSM capability.

• Serve as a senior point of accountability for CSM-related questions, escalations, study team support, and cross-functional alignment.

• Lead, coach, and develop CSM statisticians and supporting resources. Direct line management responsibilities may be in scope depending on the final operating model.

Key Responsibilities
• Lead the strategic development, operating model, roadmap, and continued evolution of Amgen’s Centralized Statistical Monitoring capability within the broader RBQM framework.
• Serve as business owner for the CSM analysis system, partnering with Digital Technology and Statistical Programming on requirements, prioritization, SDLC activities, business validation, UAT, release readiness, lifecycle management, and continuous improvement.
• Provide senior statistical and technical leadership for conventional and innovative CSM methodology, including signal development, site-level analytics, anomaly detection, risk indicators, signal thresholds, QTL-related approaches where applicable, and advanced statistical, machine learning, or AI-enabled approaches where appropriate.
• Oversee statistical review, interpretation, documentation, and release of CSM signals across clinical studies, ensuring outputs are scientifically sound, traceable, inspection-ready, and useful for study quality oversight.
• Partner with study teams, Global Statistical Leads, Global Development Operations, Data Management, Quality, RBQM, Digital Technology, and other stakeholders to support interpretation of CSM findings, issue escalation, and effective use of CSM outputs.
• Lead, coach, and develop CSM statisticians and supporting resources, including Amgen and Functional Service Provider resources as appropriate. Direct line management responsibilities may be in scope depending on the final operating model.
• Define and maintain CSM standards, guidance, training materials, operating procedures, and best practices to support consistent delivery, knowledge transfer, inspection readiness, and long-term sustainability.

We are all different, yet we all use our unique contributions to serve patients. The person we seek is a professional with these qualifications.

Basic Qualifications

Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience

OR

Master’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 12 years of relevant experience

Preferred Qualifications
• Significant statistical experience in the biopharmaceutical industry, including clinical development and clinical trial statistical oversight.
• Experience with Centralized Statistical Monitoring, RBQM, QTLs, Quality by Design, data integrity, or clinical trial quality oversight.
• Experience developing, evaluating, validating, or implementing statistical monitoring signals or regulated analytical deliverables in a production environment.
• Experience serving as a business owner, product owner, capability lead, or functional owner for an analytical, statistical, or clinical system, including SDLC activities such as requirements, UAT, business validation, release readiness, documentation, and lifecycle management.
• Strong statistical programming and analytical skills using SAS and/or R; Python experience a plus, with experience working with clinical trial, operational, EDC, metadata, or external data sources.
• Familiarity with Bayesian methods, hierarchical modeling, machine learning, advanced analytics, R Shiny, or business intelligence platforms.
• People management, functional leadership, coaching, or matrix leadership experience, including leading cross-functional initiatives.
• Strong communication skills, global collaboration skills, and understanding of regulatory and industry trends relevant to RBQM, clinical trial quality, data integrity, and centralized monitoring.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

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Salary Range