Head of Biostatistics & AI-Driven Clinical Analytics

Cook Group; West Lafayette (IN); On-site; USD 220,000 - 320,000; Full time

Job summary

Cook Group seeks a Director of Biostatistics and Clinical Data Science to lead Biostatistics and CDS and guide RWE, AI-enabled analytics, and data-driven decision support across global clinical research, regulatory strategy, post-market evidence, and product lifecycle management.

The successful candidate will lead multidisciplinary teams, partner with Regulatory Affairs, HEOR, R&D, Product Management, IT, and executive leadership to transform data into evidence, insights, and innovation.

Qualifications

• PhD required in Biostatistics, Statistics, Epidemiology, Data Science or related field.
• Minimum 10 years of progressive experience in clinical research, biostatistics or related fields.
• Experience leading multidisciplinary technical teams in regulated environments.
• Proven ability to develop RWD/RWE programs and data-driven evidence generation.
• Familiarity with AI governance and regulated analytics environments.

Responsibilities

• Provide leadership and strategic direction for Biostatistics and Clinical Data Science teams.
• Guide statistical strategy for studies, registries, and post-market evidence programs.
• Ensure scientific rigor in study design, analysis, interpretation, and reporting.
• Oversee analytical standards, methodologies, and best practices.
• Lead development of RWD/RWE strategies and cross-functional evidence initiatives.
• Collaborate with Regulatory, HEOR, R&D, IT and leadership to drive insights.

Skills

Biostatistics leadership

Clinical Data Science

Real-World Evidence

AI governance

Data governance

Education

PhD in Biostatistics or related field

Job description

Cook Group seeks a Director of Biostatistics and Clinical Data Science to lead Biostatistics and CDS and guide RWE, AI-enabled analytics, and data-driven decision support across global clinical research, regulatory strategy, post-market evidence, and product lifecycle management.

The successful candidate will lead multidisciplinary teams, partner with Regulatory Affairs, HEOR, R&D, Product Management, IT, and executive leadership to transform data into evidence, insights, and innovation.