Biostatistics Manager, Centralized Statistical Monitoring (CSM)
Amgen · Hyderabad, India
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Role summary
Amgen seeks a Biostatistics Manager to lead centralized statistical monitoring across clinical development programs. The role involves developing machine learning and statistical models, collaborating with cross-functional teams, and implementing data-driven quality oversight methods in a regulated environment.
What they're looking for
- MSc or PhD in Statistics, Biostatistics, or related field
- 8 years of industrial biostatistics experience
- Proficiency in R, SAS, or Python for statistical programming
- Experience with machine learning and advanced analytical methods
- Clinical trial experience in pharmaceutical or medical research
- Technical writing skills with documented examples
- Strong communication and cross-functional collaboration abilities
What you'll be doing
- Provide statistical and data science expertise for centralized statistical monitoring activities across multiple studies
- Develop and enhance statistical and machine learning methodologies for signal detection and risk assessment
- Perform quality control and statistical review of monitoring outputs and study-level metrics
- Collaborate with clinical, operations, and technology teams to translate business requirements into analytical solutions
- Create visualizations and dashboards to communicate monitoring results to stakeholders
Privacy & handoff
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