Director, Biostatistics and Data Science

Cook Research Inc.; West Lafayette (IN); On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Health insurance

Job summary

Cook Research Inc. in West Lafayette, IN, seeks a Director of Biostatistics and Clinical Data Science to lead teams and shape strategic directions for evidence generation across global programs.

The role emphasizes real-world data, AI-enabled analytics, regulatory science collaboration, and data platform governance to drive informed decision-making and innovation across the organization.

Qualifications

• PhD required in biostatistics or related field.
• 10+ years in clinical research or biostatistics.
• Experience with AI-enabled analytics and regulatory evidence generation.

Responsibilities

• Provide strategic leadership for Biostatistics and Data Science teams.
• Define statistical strategy for studies, registries, and post-market programs.
• Drive evidence generation using RWE, AI, and advanced analytics.
• Ensure rigor, quality, and regulatory compliance in analyses.

Skills

Biostatistics

Clinical Data Science

Real-World Evidence

AI & ML

Statistical Programming

Education

PhD in Biostatistics

Tools

R

Python

SAS

Job description

Director, Biostatistics and Data Science

Requisition ID 2026-19771

Posting Date 24 hours ago (10/20/2026 6:16 PM)

Job Location(s) West Lafayette IN United States

Job Locations US-IN-West Lafayette

Position Type Full Time

Company Cook Research Inc.

Category Clinical

Why Join Us

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.

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

Education

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)
• 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.

What Success Looks Like

• Provide clear vision and leadership for Biostatistics and Clinical Data Science teams.
• Advance Cook's capabilities in evidence generation and analytics.
• Expand the effective use of real-world data and real-world evidence.
• Enable responsible adoption of artificial intelligence and advanced analytics.
• Strengthen enterprise data and analytics capabilities.
• Build and develop high-performing technical teams.
• Serve as a trusted strategic advisor across Clinical Affairs and the broader organization.

"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.