Associate Director, Biostatistics & AI

BridgeBio Pharma

1d•$173,800 - $217,000•Hybrid

About The Position

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. The Associate Director, Biostatistics & AI is a senior individual contributor and emerging people leader responsible for the delivery of high-quality statistical analyses and for designing, building, and embedding AI/ML interfaces into the day-to-day workflows of the biometrics function. This role sits at the intersection of pharmaceutical statistical science and applied AI engineering — and is the primary internal resource for setting up, validating, and governing AI tooling in a GxP-compliant environment. A successful candidate will bring either deep pharmaceutical biometrics expertise with growing AI/ML skills, or strong AI/ML engineering experience with meaningful exposure to clinical or life sciences data. In either case, they will have the drive and aptitude to rapidly bridge both domains. They will work across cross-functional teams including Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance, and will manage CRO statisticians and programmers on assigned programs.

Requirements

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
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
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
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

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
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

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
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
Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
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 Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
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