Take Care Of Others

BiostatisticsManager,CentralizedStatisticalMonitoring(CSM)

Madurai, India FULL TIME
The Brief

“Biostatistics Manager, Centralized Statistical Monitoring (CSM) at Take Care Of Others. Skills: Biostatistics, Centralized Statistical Monitoring (CSM), machine learning, AI, statistical models. 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”

What You'll Achieve.

enhance proactive oversight of clinical trials; strengthen CSM signal detection and site-level risk assessment; ensure accuracy, consistency, and appropriate interpretation prior to stakeholder communication; analytically robust and scalable monitoring solutions; reproducibility and adherence to internal standards; enhance transparency and facilitate interpretation of monitoring outputs

Industry & Context.

Problems you'll solve

analytical skills; problem-solving

What They're Looking For.

Must Have

MSc or PhD in Statistics, Biostatistics, or related field, 8 years of Industrial experience

Nice to Have

Proficiency in statistical programming (e.g., R, SAS, or Python), 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

What You'll Do.

Provide statistical and data science expertise to support CSM activities across multiple studies and therapeutic areas

Develop and enhance statistical

and AI-guided methodologies

to strengthen CSM signal detection and site-level risk assessment

Perform detailed statistical review and quality control of CSM outputs

and study-level metrics to ensure accuracy

and appropriate interpretation prior to stakeholder communication

Contribute to validation

and controlled deployment of analytical methodologies and tools within regulated environments

ensuring reproducibility and adherence to internal standards

Develop clear visualizations

and analytical applications to enhance transparency and facilitate interpretation of monitoring outputs

Stay current with evolving developments in data science

and AI relevant to clinical trial monitoring

Adhere to all Amgen policies and Standard Operating Procedures (SOPs)

How You'll Work.

Team & Collaboration

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

Communication Scope

excellent communication skills; stakeholder communication; stakeholder collaboration

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