Associate Director, Biostatistics & AI
New
B
BridgeBio PharmaBiotechnology, Biopharma
Remote - USAFull-TimeSenior
Salary$173,800 — $217,000 USD
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Job Details
- Experience
- Track A: 5+ years (PhD) or 7+ years (Master's) pharmaceutical biostatistics experience. Track B: 3+ years of hands-on AI/ML engineering experience.
- Required Skills
- PythonArtificial IntelligenceMachine LearningRMLOps
Requirements
- PhD or Master’s degree in Biostatistics, Statistics, Computer Science, Artificial Intelligence, Data Science, or a related field.
- For Track A: 5+ years (PhD) or 7+ years (Master’s) of pharmaceutical biostatistics experience.
- For Track B: 3+ years of hands-on AI/ML engineering experience, including LLM-powered tools and RAG pipelines.
- Expert-level proficiency in SAS and/or R.
- Strong Python proficiency for AI/ML development.
- Deep knowledge of CDISC standards (SDTM, ADaM, Define-XML).
- Familiarity with regulatory frameworks (FDA, EMA, ICH, GxP, 21 CFR Part 11).
- Experience with AI governance, explainability (XAI), and bias assessment.
- Strong written and verbal communication skills.
- Ability to work effectively across cross-functional teams and manage external vendors.
Responsibilities
- Apply statistical methodologies supporting medical insights, safety monitoring, and lifecycle management.
- Contribute to statistical design, analysis, and reporting for Phase II–IV clinical trials, including Bayesian methods and ICH E9(R1) estimands.
- Design and implement AI/ML environments connecting SAS, R, and Python with enterprise LLM APIs and RAG pipelines.
- Build, test, and iterate on AI-powered tools for SAP drafting, TFL automation, and regulatory document support.
- Establish MLOps pipelines within a GxP-compliant and audit-ready framework.
- Manage CRO statisticians and programmers on assigned programs.
- Partner with cross-functional teams and IT vendors to integrate AI tools with clinical systems like EDC and CTMS.
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