Associate Director, Biostatistics & AI

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

Location: US, Remote - will have occasional/quarterly visits as needed to client's San Francisco office.

Position Overview

This role combines pharmaceutical biostatistics with applied AI/ML implementation, supporting clinical development, regulatory submissions, and the integration of AI tools into biometrics workflows. The individual will lead statistical activities, develop and validate AI-powered solutions in GxP-compliant environments, and oversee CRO statisticians and programmers.

• Key ResponsibilitiesSupport statistical design, analysis, and reporting for Phase II-IV trials, including adaptive designs, Bayesian methods, and estimands.
• Contribute to global regulatory submissions (NDA, BLA, MAA) and health authority responses.
• Develop AI/ML interfaces connecting statistical platforms, LLMs, and clinical data systems.
• Build and validate AI tools for SAP drafting, TFL automation, data quality, regulatory documentation, and submission preparation.
• Establish MLOps processes, AI governance, model monitoring, and GxP-compliant documentation.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance, IT, and external vendors.
• Manage CRO resources and develop SOPs and best practices for biostatistics, programming, and AI implementation.
• Required QualificationsPhD or Master’s in Biostatistics, Statistics, Computer Science, AI, Data Science, or a related quantitative field.
• Biostatistics-focused candidates: 5+ years of pharmaceutical biostatistics experience with a PhD or 7+ years with a Master’s; strong SAS/R skills, Python familiarity, CDISC expertise, and exposure to AI/ML tools.
• AI/ML-focused candidates: 3+ years of hands-on AI/ML engineering experience, including LLMs, RAG pipelines, agentic workflows, or MLOps; strong Python skills and exposure to clinical/life sciences data and regulated environments.
• Knowledge of statistical methodologies, clinical development, and FDA/EMA/ICH regulations.
• Strong communication, problem-solving, and cross-functional collaboration skills.
• Demonstrated initiative in developing and implementing AI-powered solutions in regulated environments.