Career Category
Research
Job Description
Biostatistics Manager, Centralized Statistical Monitoring (CSM)
What you will do:
Amgen’s Center for Design and Analysis Organization has a new opportunity for a Biostatistics Manager to provide statistical expertise in support of Centralized Statistical Monitoring (CSM) across clinical development programs.
The ideal candidate will build machine learning models and other statistical models, as well as support their implementation and deployment through a good understanding of the Software Development Life Cycle (SDLC). Develop business requirements through collaborations with cross-functional stakeholders and the use of excellent communication skills. Experience with clinical trials and their data collection process, storage, quality, and use would be looked for. The latter will be particularly critical in a regulated environment.
In this role, you will leverage your experience as a biostatistician to contribute to the design, application,
and continuous improvement of data-driven monitoring methods that support risk-based quality management (RBQM). You will apply your ML and AI skills to detect atypical data patterns, identify emerging quality risks, and enhance proactive oversight of clinical trials.
Functional requirements, prototype code, good documentation, testing, and relevant visualizations will be expected as deliverables when producing recent algorithms as required by the stakeholders.
Key responsibilities include:
- Provide statistical and data science expertise to support CSM activities across multiple studies and therapeutic areas.
- Develop and enhance statistical, machine learning, and AI-guided methodologies, to strengthen CSM signal detection and site-level risk assessment.
- Perform detailed statistical review and quality control of CSM outputs, signals, and study-level metrics to ensure accuracy, consistency, and appropriate interpretation prior to stakeholder communication.
- Collaborate with cross-function