Remote Associate Director, Biostatistics & AI/ML

Penfield Search Partners Ltd.; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Penfield Search Partners Ltd. is seeking an Associate Director of Biostatistics & AI/Data Science to blend pharmaceutical statistics with AI/ML to improve design, analysis, and regulatory submissions.

This remote US-based role supports Phase II–IV trials and regulatory documentation. You will build AI-powered tools, ensure GxP compliance, and collaborate across Clinical Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance, IT, and external vendors.

Qualifications

• PhD or MS required in Biostatistics, Statistics, CS, AI, or Data Science.
• 5+ years pharma biostatistics experience with PhD, or 7+ years with MS.
• Advanced SAS and/or R; working knowledge of Python.
• Experience with clinical trials, CDISC standards, regulatory submissions.
• Exposure to AI/ML tools and interest in expanding AI capabilities.
• Strong communication, collaboration, and problem-solving skills.

Responsibilities

• Support statistical design, analysis, and reporting for Phase II–IV trials and regulatory submissions.
• Develop and implement AI-powered tools to automate statistical programming, reporting, data quality checks, and regulatory documentation.
• Build, test, validate, and monitor AI/ML solutions in a GxP-compliant environment.
• Ensure AI tools follow applicable regulatory, documentation, and governance requirements.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance, IT, and external vendors.
• Oversee CRO statisticians and programmers on assigned programs.
• Develop SOPs and best practices for statistical analysis, programming, and AI implementation.

Job description

Penfield Search Partners Ltd. is seeking an Associate Director of Biostatistics & AI/Data Science to blend pharmaceutical statistics with AI/ML to improve design, analysis, and regulatory submissions.

This remote US-based role supports Phase II–IV trials and regulatory documentation. You will build AI-powered tools, ensure GxP compliance, and collaborate across Clinical Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance, IT, and external vendors.