Director, Biostatistics and Data Science

Cook Group

. Provide operational direction for Biostatistics and Clinical Data Science and strategic guidance on Real-World Evidence, Advanced Analytics with Artificial Intelligence, and data-driven decision support .

Posted 10/20/2026full-timeWest Lafayette • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Biostatistics, Clinical Data Science, and Real-World Evidence, with a strong focus on leading multidisciplinary teams and guiding statistical strategies for clinical studies. Proficient in advanced analytics, artificial intelligence applications, and regulatory compliance within healthcare environments.

Highest-signal resume keywords

PhD In BiostatisticsClinical Research ExperienceLeadership Of Multidisciplinary TeamsReal-World Evidence DevelopmentArtificial Intelligence Applications

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study DesignStatistical MethodologyData ScienceAdvanced AnalyticsData GovernanceMachine Learning ApplicationsRegulatory Evidence GenerationAnalytics PlatformsQuantitative ResearchEvidence Generation

Soft Skills

MentoringStrategic AdvisingCollaborationInfluencing Decision-MakingTalent Development

Tools & Technologies

Data IntegrationScalable Analytics WorkflowsEnterprise Analytics PlatformsKnowledge Management SystemsAI-Enabled Workflows

Industry Keywords

HealthcareClinical Data ScienceBiostatisticsReal-World DataRegulatory ComplianceMedical Device IndustryFDA InteractionScientific PublicationHealth EconomicsDigital Transformation

About the role

Key responsibilities & impact

Provide operational direction for Biostatistics and Clinical Data Science and strategic guidance on Real-World Evidence, Advanced Analytics with Artificial Intelligence, and data-driven decision support
Lead multidisciplinary Biostatistics and Clinical Data Science teams
Guide statistical strategy for clinical studies, registries, post-market surveillance programs, and evidence-generation initiatives
Ensure rigor and technical excellence in study design, analysis, interpretation, and communication of clinical evidence
Oversee analytical standards, methodologies, and best practices
Lead development and execution of real-world data and real-world evidence strategies
Evaluate internal and external data sources for evidence generation
Support regulatory, reimbursement, health economics, scientific publication, and business decision-making needs
Identify and prioritize opportunities for artificial intelligence and advanced analytics
Guide responsible and ethical adoption of AI-enabled workflows and establish governance for risk management, transparency, quality, and regulatory compliance
Lead development and adoption of enterprise analytics and data platform capabilities
Support data integration, scalable analytics workflows, knowledge management, and self-service analytics
Sponsor 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 across clinical, regulatory, analytics, and innovation initiatives
Serve as 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

Requirements

What you’ll need

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

Benefits

Comp & perks

Equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class
Consideration of qualified applicants with criminal histories consistent with applicable federal, state/province and local law