BridgeBio · 2 weeks ago
Associate Director, Biostatistics & AI
United States
Full-time
Remote
Lead/Staff, Director/Executive
$174K/yr - $217K/yr
5+ years expBridgeBio is a company pioneering a unique approach in biotech to develop life-changing medicines for patients with unmet needs. The Associate Director, Biostatistics & AI is responsible for delivering high-quality statistical analyses and embedding AI/ML interfaces into the biometrics function, working across cross-functional teams and managing CRO statisticians and programmers.
BiotechnologyHealthcareLife SciencePharmaceuticalHealth CareMedical
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
Qualification
Required
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
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
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
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
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
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
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
501-1000 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
36%
Represents job field similar to this job
Engineering and Development
Management and Executive
Legal and Compliance
Customer Service and Support
Accounting and Finance
Trends of Total Sponsorships
*2026 (3)
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$5.9BKey Investors
Sixth StreetBlue OwlQatar Investment Authority
2026-07-01Post Ipo Equity· $1B
2026-01-16Post Ipo Debt· $550M
2025-02-25Post Ipo Debt· $500M
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
BioWorld Financial Watch
2026-07-03
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-07-02
Company data provided by crunchbase