Biostatistics & AI Associate Director — Remote

Penfield-Search-Partners-2; San Francisco (CA); Remote; USD 180,000 - 270,000; Full time

Job summary

Penfield Search Partners is seeking an Associate Director, Biostatistics & AI for a remote role with an established biotech. The position combines pharmaceutical statistics with AI/ML to improve trial design, analysis, and regulatory submissions.

You will lead statistical design for Phase II–IV trials, develop AI-powered tools to automate programming and data quality checks, and ensure compliance in a GxP environment.

Qualifications

• PhD or Master’s degree in Biostatistics, Statistics, Computer Science, AI, Data Science, or related field.
• 5+ years pharma biostatistics with PhD, or 7+ years with Master’s.
• Exposure to AI/ML tools and regulatory submissions.
• Experience with clinical trials, CDISC standards, and regulatory submissions.

Responsibilities

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

Skills

Biostatistics

AI/ML

Clinical research

Regulatory science

Education

PhD in Biostatistics or related field

Master’s in related field

Tools

SAS

R

Python

LLMs / AI tooling

Job description

Penfield Search Partners is seeking an Associate Director, Biostatistics & AI for a remote role with an established biotech. The position combines pharmaceutical statistics with AI/ML to improve trial design, analysis, and regulatory submissions.

You will lead statistical design for Phase II–IV trials, develop AI-powered tools to automate programming and data quality checks, and ensure compliance in a GxP environment.