Associate Director, Biostatistics & AI

Responsibilities

• Pharmaceutical Biostatistics
• 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)
• AI Interface Setup & Implementation
• 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
• Where You'll Work
• This is a U.S.-based remote role. Quarterly visits to our [City, State] office, or as needed based on program requirements.

Requirements

• PhD or Master's degree in Biostatistics, Statistics, Computer Science, Artificial Intelligence, Data Science, or a closely related quantitative field
• We recognize that strong candidates may come from different professional paths. We welcome applications from either of the following profiles:
• Track A - Biostats-First with Applied AI Skills
• 5+ years (PhD) or 7+ years (Master's) of pharmaceutical biostatistics experience in drug development, biotech, or CRO settings
• Expert-level proficiency in SAS and/or R; working knowledge of Python for data science or scripting
• Demonstrated exposure to AI/ML tools - such as LLM APIs, prompt engineering, or automation scripting - with a strong interest in expanding these capabilities in a GxP environment
• Deep knowledge of CDISC standards (SD

Benefits

Additional Information

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at bridgebio? Share your experience