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Associate Director, Biostatistics & AI

3 months, 4 weeks ago
United States
Full-time
Lead
AI (Artificial Intelligence)
Software Development
Machine Learning MLOps Python R
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bridgebiowp

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 7

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

Apply Now

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