Associate Director, Biostatistics & AI

What You’ll Do

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 San Francisco, CA office, or as needed based on program requirements.
• Who You Are
• 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 (SDTM, ADaM, Define-XML) and regulatory submission workflows; experience contributing to NDA/BLA/MAA preferred
• Track B — AI/ML-First with Pharma/Biostats Exposure
• 3+ years of hands-on AI/ML engineering experience, including building and deploying LLM-powered tools, RAG pipelines (LangChain or equivalent), agentic workflows, and/or MLOps infrastructure
• Strong Python proficiency for AI/ML development; working familiarity with SAS and/or R in a statistical or data science context
• Meaningful exposure to clinical or life sciences data — e.g., working with clinical trial datasets, CDISC standards, pharmacovigilance data, or regulated environments (GxP/21 CFR Part 11) — with eagerness to deepen this domain expertise
• Foundational understanding of statistical concepts (e.g., hypothesis testing, regression, survival analysis) relevant to clinical development
• All Candidates
• Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments (FDA, EMA, ICH)
• Excellent written and verbal communication skills, with the ability to engage both technical and non-technical audiences
• Ability to work as part of a cross-functional team in a fast-paced environment and collaborate effectively with external partners and vendors
• You demonstrate genuine curiosity and initiative in building and deploying AI-powered tools — not just adopting them
• Rewarding Those Who Make the Mission Possible
• We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
• Financial 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
• Health & Wellbeing
• · Comprehensive health care with 100% premiums covered - no cost to you and dependents
• · Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• · Hybrid work model - employees have the autonomy in where and how they do their work
• · Unlimited flexible paid time off - take the time that you need
• · 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 via Forkable on days worked from our office
• Skill Development & Career Paths
• · People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• · We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• · We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
• As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
• For BridgeBio Full-Time U.S Based Roles:
• Financial & Rewards
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in-office days
• Health & Well-Being
• 100% employer-paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
• Fertility & family-forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility
• Flexible, “take-what-you-need” paid time off and company-paid holidays
• Comprehensive paid medical and parental leave to care for yourself and your family
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching