Associate Director, Biostatistics & AI for Clinical Trials

Penfield Search Partners Ltd

San Francisco (CA)

Hybrid

USD 180,000 - 230,000

Full time

2 days ago

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Job summary

Penfield Search Partners Ltd invites applications for an Associate Director, Biostatistics & AI. The role blends pharmaceutical statistics with AI/ML to enhance trial design, analysis, and regulatory submissions, with development of AI-powered tools for automation and data quality in a regulated setting.

Candidates may come from pharmaceutical biostatistics with AI experience or AI/ML engineering with life sciences exposure.

Qualifications

PhD or Master’s required in biostatistics, statistics, CS, AI, data science, or related field.
Advanced SAS and/or R skills; Python knowledge.
Experience with clinical trials, CDISC standards, regulatory submissions.
Exposure to AI/ML tools; strong interest in AI capabilities.
3+ years hands-on AI/ML engineering experience.

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, and data quality checks.
Build, test, validate, 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, Pharmacovigilance, IT, and vendors.
Oversee CRO statisticians and programmers on assigned programs.
Develop SOPs and best practices for statistical analysis, programming, and AI implementation.