Director, Biostatistics and Data Science

The position offers a unique opportunity to influence the future of clinical evidence generation and analytics within a global medical device organization.

This role sits at the intersection of Clinical Research, Regulatory Science, Biostatistics, Clinical Data Science, Real-World Evidence, Artificial Intelligence, Advanced Analytics, and Digital Transformation.

The individual selected for this role will have a significant opportunity to shape how Cook generates clinical evidence, leverages the data, adopts AI technologies, and supports innovation across the organization.

The individual selected for this role will have a significant opportunity to shape how Cook generates clinical evidence, leverages the data, adopts AI technologies, and supports innovation across the organization.

Cook Research Incorporated is seeking an innovative and strategic leader to serve as Director of Biostatistics and Clinical Data Science. This leader will provide operational direction for Biostatistics and Clinical Data Science and strategic guidance to the use of Real-World Evidence, Advanced Analytics with Artificial Intelligence, and data-driven decision support capabilities that support global clinical research, regulatory strategy, post-market evidence generation, and product lifecycle management.

The successful candidate will lead multidisciplinary teams responsible for Biostatistics and Clinical Data Science. Technical specialties include biostatistics, data engineering, advanced analytics, and emerging AI-enabled capabilities. This role sits within the clinical research arm of Cook Medical and will partner extensively with Regulatory Affairs, HEOR, R&D, Product Management, IT, executive leadership, and others to transform data into evidence, insights, and innovation.

• Provide leadership and strategic direction for Biostatistics and Clinical Data Science teams.
• Guide statistical strategy for clinical studies, registries, post-market surveillance programs, and evidence-generation initiatives.
• Ensure scientific rigor and technical excellence in study design, analysis, interpretation, and communication of clinical evidence.
• Oversee development and implementation of analytical standards, methodologies, and best practices.

• Lead development and execution of real-world data (RWD) and real-world evidence (RWE) strategies.
• Evaluate opportunities to leverage internal and external data sources for evidence generation.
• Support regulatory, reimbursement, health economics, scientific publication, and business decision-making needs through innovative evidence approaches.
• Collaborate across functions to identify and address evidence gaps throughout the product lifecycle.

• Identify and prioritize opportunities to leverage artificial intelligence and advanced analytics techniques.
• Guide responsible and ethical adoption of AI-enabled workflows that improve productivity, decision support, and evidence generation.
• Establish governance that ensure appropriate risk management, transparency, quality, and regulatory compliance.
• Promote an understanding and adoption of AI technologies.

• Provide leadership for development and adoption of enterprise analytics and data platform capabilities.
• Support data integration, scalable analytics workflows, knowledge management, and self-service analytics solutions.
• Sponsor high-value analytical and AI proof-of-concept initiatives.
• Improve accessibility and usability of research, clinical, and operational data assets.

• Lead, mentor, and develop managers and technical professionals.
• Build organizational capability through workforce planning, talent development, succession planning, and recruiting.
• Allocate resources effectively across a diverse portfolio of clinical, regulatory, analytics, and innovation initiatives.
• Foster a culture of scientific rigor, collaboration, innovation, quality, and continuous improvement.

• Serve as a strategic advisor to Clinical Affairs and organizational leadership.
• Partner with Regulatory Affairs, HEOR, R&D, Quality, Product Management, and IT leaders.
• Represent the organization in scientific, regulatory, academic, and industry collaborations.
• Influence organizational strategy through data-driven decision making and evidence-based recommendations.

Education

PhD…