Associate Director, Biostatistics & AI

The role

This senior individual contributor and emerging people leader delivers high-quality statistical analyses and designs AI/ML interfaces for biometrics workflows. The role works at the intersection of pharmaceutical statistical science and applied AI engineering to set up and govern AI tooling in a GxP-compliant environment.

What you will do

• Apply statistical methodologies for medical insights, safety monitoring, and lifecycle management
• Contribute to statistical design, analysis, and reporting for Phase II–IV clinical trials
• Contribute to NDA, BLA, MAA, and other global regulatory submissions
• Design and implement AI/ML interface environments connecting biometric platforms with LLM APIs and RAG pipelines
• Build, test, and iterate on AI-powered tools for SAP drafting and TFL automation
• Establish and maintain MLOps pipelines within a GxP-compliant framework
• Implement AI governance standards including explainability and bias assessment
• Evaluate and deploy AI-powered automation for CDISC mapping and data cleaning
• Partner with IT and third-party vendors to integrate AI tools with clinical systems
• Manage CRO statisticians and programmers on assigned programs

Required qualifications

• PhD or Master’s degree in Biostatistics, Statistics, Computer Science, Artificial Intelligence, Data Science, or a closely related quantitative field
• 5+ years (PhD) or 7+ years (Master’s) of pharmaceutical biostatistics experience in drug development, biotech, or CRO settings (Track A)
• Expert-level proficiency in SAS and/or R
• Working knowledge of Python for data science or scripting (Track A)
• 3+ years of hands-on AI/ML engineering experience (Track B)
• Strong Python proficiency for AI/ML development (Track B)
• Working familiarity with SAS and/or R in a statistical or data science context (Track B)
• Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments (FDA, EMA, ICH)
• Excellent written and verbal communication skills

Nice to have

• Demonstrated exposure to AI/ML tools such as LLM APIs, prompt engineering, or automation scripting
• Experience contributing to NDA/BLA/MAA
• Building and deploying LLM-powered tools, RAG pipelines, agentic workflows, and/or MLOps infrastructure
• Meaningful exposure to clinical or life sciences data

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• 100% employer-paid medical, dental, and vision premiums for employee and dependents
• Mental health support via Spring Health
• Unlimited flexible paid time off
• Paid parental leave (4 months for birthing parents, 2 months for non-birthing parents)
• Flex spending accounts
• Company-provided group term life & disability
• Subsidized lunch and parking on in-office days

About the company

BridgeBio uses a moneyball for biotech approach, pooling projects and promising early-stage research from academia to reduce risk and unleash innovation. They build bridges to groundbreaking advancements in rare disease and develop medicines for patients with unmet needs.