Associate Director, Biostatistics & AI

Responsibilities

• Apply appropriate statistical methodologies supporting medical insights, value demonstration, safety monitoring, and lifecycle management
• Contribute to statistical design, analysis, and reporting for Phase II–IV clinical trials, including adaptive designs, Bayesian methods, and estimands under ICH E9(R1)
• Contribute to NDA, BLA, MAA, and other global regulatory submissions as lead or co-statistician; support responses to health authority queries
• Stay current with FDA, EMA, and ICH guidance on statistical methodology, and real-world evidence (RWE)

• Design and implement AI/ML interface environments connecting biometric platforms (SAS, R, Python) with enterprise LLM APIs, RAG pipelines, and clinical data repositories
• Build, test, and iterate on AI-powered tools for SAP drafting, TFL automation, anomaly detection, protocol deviation identification, and regulatory document support
• Establish and maintain MLOps pipelines for model development, validation, deployment, and monitoring within a GxP-compliant, audit-ready framework
• Implement AI governance standards including explainability (SHAP/XAI), bias assessment, and 21 CFR Part 11 / EU Annex 11 compliant documentation
• Evaluate and deploy AI-powered automation for CDISC mapping, data cleaning, and submission package preparation
• Partner with IT and third-party vendors to integrate AI tools with EDC, CTMS, RTSM, and pharmacovigilance systems

Cross-Functional Collaboration & CRO Oversight

• Translate statistical and AI concepts into clear, actionable insights for medical, regulatory, and commercial stakeholders
• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance to align biometrics and AI deliverables with program timelines
• Develop and maintain SOPs, work instructions, and best practices for biostatistics, AI tooling, and statistical programming