Associate Director, Biostatistics & AI

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. What You’ll Do 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. 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 At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary $173,800 — $217,000 USD 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 USA based roles: Financial & Rewards Market-leading compensation 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 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, & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

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