Biostatistics & AI Innovation Lead (Remote)

Redbock - an NES Fircroft company; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Redbock - an NES Fircroft company seeks a Biostatistics leader to integrate AI/ML into regulated biometrics workflows for clinical development and submissions. You will guide statistical design, develop AI-powered interfaces, and oversee CRO statisticians in a GxP context.

The role emphasizes SAS/R, Python, CDISC, and AI/ML experience within life sciences, with remote work and occasional SF client visits.

Qualifications

• This role requires PhD or Master’s in a quantitative field with biostatistics focus.
• Experience in pharmaceutical statistics with SAS/R and CDISC is required.
• Hands-on AI/ML engineering including LLMs and MLOps is preferred.

Responsibilities

• Support statistical design, analysis and reporting for Phase II–IV trials, incl. adaptive designs and estimands.
• Contribute to regulatory submissions (NDA/BLA/MAA) and health authority responses.
• Develop AI/ML interfaces linking statistical platforms, LLMs, and clinical data systems.
• Build and validate AI tools for SAP drafting, TFL automation, and regulatory docs.
• Establish MLOps, AI governance, model monitoring, and GxP documentation.
• Collaborate with Clinical Development, Regulatory, Medical Affairs, PV, IT and vendors.
• Manage CRO resources and develop SOPs for biostatistics, programming and AI implementation.

Skills

SAS

R

Python

CDISC

AI/ML

FDA/EMA regulations

Education

PhD or Master’s in Biostatistics/Statistics/CS/Data Science

Tools

LLMs

Job description

Redbock - an NES Fircroft company seeks a Biostatistics leader to integrate AI/ML into regulated biometrics workflows for clinical development and submissions. You will guide statistical design, develop AI-powered interfaces, and oversee CRO statisticians in a GxP context.

The role emphasizes SAS/R, Python, CDISC, and AI/ML experience within life sciences, with remote work and occasional SF client visits.