Director, Biostatistics and Data Science

Cook Group•West Lafayette, IN

About The Position

Cook Research Incorporated is seeking an innovative, strategic leader to provide operational direction for Biostatistics and Clinical Data Science and strategic guidance on Real-World Evidence, advanced analytics, artificial intelligence, and data-driven decision support. The role supports global clinical research, regulatory strategy, post-market evidence generation, and product lifecycle management within Cook Medical’s clinical research organization. The Director leads multidisciplinary teams with expertise in biostatistics, data engineering, advanced analytics, and emerging AI-enabled capabilities. The role partners extensively with Regulatory Affairs, HEOR, R&D, Product Management, IT, executive leadership, and other stakeholders to turn data into evidence, insights, and innovation. The position offers an opportunity to influence clinical evidence generation, data use, AI adoption, and innovation across a global medical device organization.

Requirements

PhD in 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.
At least 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.
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.

Nice To Haves

Experience within the medical device industry.
Experience interacting with FDA, notified bodies, PMDA, NMPA, or other global regulatory authorities.
Experience developing real-world data and real-world evidence 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.

Responsibilities

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 and real-world evidence strategies.
Evaluate opportunities to use internal and external data sources for evidence generation.
Support regulatory, reimbursement, health economics, scientific publication, and business decision-making through innovative evidence approaches.
Collaborate across functions to identify and address evidence gaps throughout the product lifecycle.
Identify and prioritize opportunities to use artificial intelligence and advanced analytics.
Guide responsible and ethical adoption of AI-enabled workflows to improve productivity, decision support, and evidence generation.
Establish governance to ensure appropriate risk management, transparency, quality, and regulatory compliance.
Promote understanding and adoption of AI technologies.
Lead 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 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.