Director, Biostatistics and Data Science

Overview

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.

Responsibilities

Biostatistics and Clinical Data Science Leadership

• 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.

Real-World Data and Evidence Strategy

• 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.

Artificial Intelligence and Digital Transformation

• 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.

Data Platform Strategy

• 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.

Organizational Leadership

• 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.

Cross-Functional Leadership

• 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.

Qualifications

PhD required in one of the following disciplines: Biostatistics, Statistics, Epidemiology, Data Science, Biomedical Informatics, Computational Biology, Computer Science (with significant healthcare or clinical analytics experience), Biomedical Engineering (with significant quantitative research experience), or a related quantitative discipline.

Experience

• Minimum 10 years of progressive experience in clinical research, biostatistics, clinical data science, epidemiology, real-world evidence, advanced analytics, or related fields.
• Demonstrated experience leading multidisciplinary technical teams.
• Experience supporting clinical research and evidence-generation programs in regulated healthcare environments.

Technical Expertise

Candidates should possess significant experience in several of the following areas:

• Clinical study design and statistical methodology
• Clinical research and medical device development
• Regulatory evidence generation
• Real-world data and real-world evidence
• Data science and advanced analytics
• Data governance and quality systems
• Artificial intelligence and machine learning applications
• Analytics platforms and modern data ecosystems
• Scientific publication and presentation activities

Preferred Qualifications

• Experience within the medical device industry.
• Experience interacting with FDA, notified bodies, PMDA, NMPA, or other global regulatory authorities.
• Experience developing RWD/RWE programs.
• Experience with AI governance and implementation in regulated environments.
• Experience leading organizational or digital transformation initiatives.
• Record of scientific publications, conference presentations, or broader professional engagement.
• Experience collaborating with academic institutions, registries, healthcare systems, or external research partners.