bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals

Health Care

251-1K (420)

Founded 2014

$2300M raised

36 open positions

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Associate Director, Biostatistics & AI

3 days, 23 hours ago

United States

Full-time

Lead

AI (Artificial Intelligence)

Software Development

Machine Learning MLOps Python R

Apply Now

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals

251-1K

Founded 2014

$2300M raised

View All Jobs 36

Description

Apply appropriate statistical methodologies to support 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).
Support NDA, BLA, MAA, and other global regulatory submissions as lead or co-statistician, and respond to health authority queries.
Design and implement AI/ML interface environments that connect SAS, R, and 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 in a GxP-compliant, audit-ready framework.
Implement AI governance standards including explainability, 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 external vendors to integrate AI tools with EDC, CTMS, RTSM, and pharmacovigilance systems.
Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance to align biometrics and AI deliverables with program timelines.

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, or 3+ years of hands-on AI/ML engineering experience.
Expert-level proficiency in SAS and/or R, with working knowledge of Python for data science, scripting, or AI/ML development.
Demonstrated exposure to AI/ML tools such as LLM APIs, prompt engineering, RAG pipelines, agentic workflows, automation scripting, or MLOps infrastructure.
Deep knowledge of CDISC standards, including SDTM, ADaM, and Define-XML, and regulatory submission workflows.
Experience contributing to NDA, BLA, or MAA submissions is preferred.
Meaningful exposure to clinical or life sciences data, including clinical trial datasets, pharmacovigilance data, or regulated GxP environments, is preferred.
Foundational understanding of statistical concepts such as hypothesis testing, regression, and survival analysis.
Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments including FDA, EMA, and ICH.
Excellent written and verbal communication skills, with the ability to engage both technical and non-technical audiences.

Benefits

Market-leading compensation with an annual performance bonus and company equity.
401(k) with 100% employer match on the first 3% and 50% on the next 2%.
Employee stock purchase program.
Comprehensive health coverage with 100% employer-paid medical, dental, and vision premiums for employees and dependents.
Health Savings Account with annual employer contributions, plus Flexible Spending Accounts.
Mental health support through Spring Health, including therapy and coaching sessions.
Hybrid work model with a U.S.-based remote setup and quarterly office visits as needed.
Unlimited flexible paid time off plus company-paid holidays.
Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents.
Pre-tax commuter benefits, referral bonus, subsidized lunch on in-office days, and access to professional development programs.

Interested in this position?

Apply directly on the company website

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