Biostatistics Manager, Centralized Statistical Monitoring (CSM) Job at Amgen (Hyderabad)

Job Responsibility

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-functional partners (e.g., Clinical, Operations, Data Management, RBQM, Quality, Digital/Technology teams) to translate critical-to-quality (CTQ) factors into analytically robust and scalable monitoring solutions
Contribute to validation, documentation, and controlled deployment of analytical methodologies and tools within regulated environments, ensuring reproducibility and adherence to internal standards
Develop clear visualizations, dashboards, and analytical applications to enhance transparency and facilitate interpretation of monitoring outputs
Stay current with evolving developments in data science, machine learning, and AI relevant to clinical trial monitoring
Adhere to all Amgen policies and Standard Operating Procedures (SOPs)

MSc or PhD in Statistics, Biostatistics, or related field with 8 years of Industrial experience
Proficiency in statistical programming (e.g., R, SAS, or Python) with 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, with responsibility for study-level statistical analysis and reporting
Experience working effectively in a globally dispersed team environment with cross-cultural partners
Demonstrable strategic thinking skills, originality, and creativity
Writing skills with samples of technical writing (papers, reports, or project descriptions)
Self-directed, and well organized

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible