> Markdown version of [/jobs/ext/2281790-centralized-statistical-monitoring-director](https://www.wearedevelopers.com/jobs/ext/2281790-centralized-statistical-monitoring-director). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Centralized Statistical Monitoring, Director

- **Company:** Amgen
- **Location:** Washington, DC, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Artificial Intelligence, Data Analysis, Data Integrity, DevOps, Digital Technology, R (Programming Language), Python (Programming Language), Machine Learning, Metadata, Systems Development Life Cycle, SAS (Software), Data Management, GXP
- **Published:** August 28, 2026
- **Apply:** https://www.biospace.com/logon?PipelinedPage=%2Fjob%2F3070744%2Fcentralized-statistical-monitoring-director%3FAction%3DContinueJobApplication%23application-form

## About the Role

Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience, Masters degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 12 years of relevant experience, 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.

## Description

Lets do this. Lets 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 Amgens 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 Amgens 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., Lead the strategic development, operating model, roadmap, and continued evolution of Amgens 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.


## Related Videos

- [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture)
- [A Data Mesh needs Open Metadata](https://www.wearedevelopers.com/videos/505-a-data-mesh-needs-open-metadata)
- [From DevOps to Scaled DevOps: How We’re Rebuilding Continuous Delivery as a Platform](https://www.wearedevelopers.com/videos/100018-from-devops-to-scaled-devops-how-we-re-rebuilding-continuous-delivery-as-a-platform)
- [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery)
- [Crafting Custom Frameworks with Rust: A Deep Dive into Procedural Macros](https://www.wearedevelopers.com/videos/849-crafting-custom-frameworks-with-rust-a-deep-dive-into-procedural-macros)
- [DevOps Maturity Check – a way to balance autonomy and alignment](https://www.wearedevelopers.com/videos/58-devops-maturity-check-a-way-to-balance-autonomy-and-alignment)

## Related Articles

- [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk)
- [Coffee with Developers - Maria Apazoglou - Making AI understandable for all in production](https://www.wearedevelopers.com/magazine/475-coffee-with-developers-maria-apazoglou-making-ai-understandable-for-all-in-production)
- [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again)
- [Everything a Developer Needs to Know About MCP with Neo4j](https://www.wearedevelopers.com/magazine/604-everything-a-developer-needs-to-know-about-mcp-with-neo4j)
- [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers)
- [How to Become an AI Engineer](https://www.wearedevelopers.com/magazine/331-how-to-become-an-ai-engineer)