Biostatistics Manager, Centralized Statistical Monitoring (CSM)
Location: Hyderabad, India
Department: Research
Job Overview
The Biostatistics Manager, Centralized Statistical Monitoring (CSM) will provide statistical expertise to support Risk-Based Quality Management (RBQM) and Centralized Statistical Monitoring activities across clinical development programs. The role focuses on applying advanced statistical methods, machine learning, artificial intelligence, and data science techniques to identify quality risks, detect unusual data patterns, and improve oversight of clinical trials.
This position requires strong expertise in clinical trial statistics, data analytics, machine learning model development, and software development practices within a regulated pharmaceutical environment.
Key Responsibilities
Centralized Statistical Monitoring & Risk Assessment
Provide statistical and data science expertise to support CSM activities across multiple clinical studies and therapeutic areas.
Design, develop, and enhance statistical monitoring methodologies for clinical trial oversight.
Apply machine learning and AI-based approaches to improve signal detection and site-level risk assessment.
Identify atypical data patterns, emerging risks, and quality issues through advanced analytical techniques.
Support Risk-Based Quality Management (RBQM) initiatives through data-driven monitoring strategies.
Statistical Analysis & Quality Control
Conduct detailed statistical review of monitoring outputs, signals, and study-level metrics.
Perform quality control checks to ensure accuracy, consistency, and reliability of analytical results.
Interpret statistical findings and communicate insights to stakeholders.
Ensure appropriate documentation and traceability of analytical outputs.
Machine Learning & Data Science
Build, validate, and deploy machine learning models for clinical trial monitoring.
Develop predictive and risk-based analytical models.
Apply AI and advanced statistical methodologies to improve monitoring effectiveness.
Continuously evaluate and improve existing algorithms and monitoring approaches.
Software Development & Deployment
Support implementation and deployment of analytical solutions using Software Development Life Cycle (SDLC) principles.
Develop functional requirements and prototype analytical applications.
Create technical documentation, testing plans, and validation packages.
Ensure solutions are reproducible, scalable, and compliant with regulatory requirements.
Cross-Functional Collaboration
Collaborate with:
Clinical Operations
Data Management
RBQM Teams
Quality Functions
Digital & Technology Teams
Translate Critical-to-Quality (CTQ) factors into robust analytical monitoring solutions.
Gather business requirements and align analytical solutions with stakeholder needs.
Data Visualization & Reporting
Develop dashboards, visualizations, and analytical applications to support data interpretation.
Present complex analytical findings in a clear and actionable manner.
Enhance transparency of monitoring outputs through interactive reporting tools.
Compliance & Continuous Improvement
Contribute to validation, documentation, and controlled deployment of analytical methodologies.
Ensure compliance with internal policies, SOPs, and regulatory requirements.
Stay current with advancements in:
Data Science
Machine Learning
Artificial Intelligence
Clinical Trial Analytics
Basic Qualifications
MSc or PhD in:
Statistics
Biostatistics
Related Quantitative Discipline
Minimum 8 years of industry experience.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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