Associate Director Biostatistics and AI/Data Science

Penfield-Search-Partners-2; 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

Associate Director, Biostatistics & AI/Data Science - RemoteOur client is an established biotech whose latest need is for an Associate Director, Biostatistics & AI to combine pharmaceutical statistical expertise with artificial intelligence and machine learning (AI/ML) to improve clinical development workflows. This role will support clinical trial design, statistical analysis, regulatory submissions, and the development of AI-powered tools that automate processes, improve data quality, and increase efficiency. You will also help ensure AI solutions meet applicable pharmaceutical quality, compliance, and regulatory requirements.***Please Note: We welcome candidates from either a pharmaceutical biostatistics background with applied AI experience or an AI/ML engineering background with exposure to clinical or life sciences data.Key ResponsibilitiesSupport statistical design, analysis, and reporting for Phase II–IV clinical 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.QualificationsCandidates should hold a PhD or Master’s degree in Biostatistics, Statistics, Computer Science, AI, Data Science, or a related field and meet the requirements of one of the following pathways.Pathway A: Biostatistics-Focused5+ years of pharmaceutical biostatistics experience with a PhD, or 7+ years with a Master’s degree.Advanced SAS and/or R skills, with working knowledge of Python.Experience with clinical trials, CDISC standards, and regulatory submissions.Exposure to AI/ML tools and a strong interest in expanding AI capabilities.Pathway B: AI/ML-Focused3+ years of hands-on AI/ML engineering experience.Strong Python skills and experience with LLMs, RAG pipelines, AI workflows, or MLOps.Exposure to clinical or life sciences data and familiarity with statistical concepts.Working knowledge of SAS and/or R and an interest in pharmaceutical development.All CandidatesStrong communication, collaboration, and problem-solving skills.Understanding of applicable statistical and regulatory principles relevant to their background.A proactive approach to building and implementing AI-powered solutions in a regulated environment.If you are interested to learn more, please send me a message to [e-mail]!