Director, Clinical Data Analytics

Strategy & Transformation

• Define and execute the global Clinical Data Analytics strategy and multi-year capability roadmap.
• Translate GCRO and enterprise priorities into functional priorities, investments, and transformation initiatives.
• Identify and advance emerging capabilities and technologies that improve speed, quality, efficiency, and value of evidence generation.
• Serve as the senior functional advisor for statistics, clinical data, and AI.
• Drive transformation through standardization, automation, data integration, and responsible adoption of AI.

Functional Leadership

• Biostatistics: Provide scientific and technical leadership for statistical activities supporting clinical investigations, registries, post-market evidence generation, health economic analyses, and real-world evidence programs.
• Ensure statistical rigor in study design, protocol development, sample-size determination, statistical analysis plans, and interpretation of study outcomes.
• Oversee statistical support for regulatory submissions, clinical study reports, publications, presentations, and external communications.
• Clinical Data Management & Governance: Lead global clinical data management strategy, standards, and operations.
• Oversee the clinical data lifecycle including data acquisition, eCRF and database design, validation, reconciliation, coding, quality review, and database lock.
• Establish and maintain data governance frameworks, standards, lineage, and controls.
• AI, Data Science & Advanced Analytics: Lead development and deployment of AI, machine learning, predictive analytics, and advanced data science capabilities.
• Provide functional oversight for synthetic data, virtual twins, simulation modeling, predictive analytics, and other advanced evidence-generation methodologies.
• Statistical & Clinical Programming: Lead statistical programming and clinical programming capabilities.
• Provide oversight for clinical data architecture, the Clinical Data Lake, data pipelines, system integrations, standardized data models, and analytics infrastructure.

People Leadership & Talent Development

• Lead and develop a multidisciplinary global organization of people managers, technical leaders, and individual contributors.
• Establish the organizational structure, workforce and succession plans, and capability roadmap.
• Recruit, retain, coach, and develop high-performing talent and future leaders.
• Own performance management, development planning, career development, and employee engagement.
• Foster an inclusive culture of scientific excellence, innovation, accountability, collaboration, quality, and continuous learning.

Regulatory, Quality & Compliance Oversight

• Ensure clinical data analytics activities comply with applicable regulations, company procedures, data privacy requirements, and quality standards.
• Represent the function during audits, inspections, and regulatory interactions.
• Support regulatory submissions and responses involving statistical methodology, data management practices, programming outputs, data architecture, and analytical approaches.
• Maintain inspection readiness and proactively identify and mitigate operational, quality, data integrity, and compliance risks.

Cross-Functional Partnership & External Engagement

• Partner with Clinical Research, Medical Affairs, Regulatory Affairs, Quality, R&D, Digital, Health Economics, IT, and business-unit leaders.
• Influence clinical development and evidence-generation strategies through scientific expertise and data-driven insights.
• Build effective relationships with CROs, technology providers, external experts, academic collaborators, and industry organizations.

Financial & Operational Management

• Develop and manage the functional budget, resource plan, vendor strategy, and technology investments.
• Monitor performance indicators and functional metrics.
• Drive continuous improvement and operating-model efficiencies.