Associate Director, Biostatistics & AI
BridgeBio
June 30, 2026
Remote
United States
Clinical Research and Development
What You’ll Do
- Deliver high-quality statistical analyses and design/build/embed AI/ML interfaces into biometrics workflows.
- Serve as primary internal resource for setting up, validating, and governing AI tooling in a GxP-compliant environment.
- Bridge pharmaceutical statistical science and applied AI engineering; manage CRO statisticians/programmers.
Responsibilities
- Pharmaceutical Biostatistics
- Apply statistical methods for medical insights, value demonstration, safety monitoring, lifecycle management.
- Support Phase II–IV clinical trial design/analysis/reporting (adaptive designs, Bayesian methods, estimands under ICH E9(R1)).
- Lead/co-lead statistics for NDA/BLA/MAA and respond to health authority queries.
- AI Interface Setup & Implementation
- Build AI/ML interface environments (SAS/R/Python with LLM APIs, RAG pipelines, clinical repositories).
- Develop AI tools (SAP drafting, TFL automation, anomaly detection, protocol deviation ID, regulatory support).
- Implement MLOps pipelines for GxP audit-ready model development/validation/deployment/monitoring.
- Apply AI governance (SHAP/XAI, bias assessment, 21 CFR Part 11/EU Annex 11 documentation).
- Automate CDISC mapping, data cleaning, submission package prep; integrate with EDC/CTMS/RTSM/pharmacovigilance.
- Cross-Functional Collaboration & CRO Oversight
- Translate stats/AI concepts for medical/regulatory/commercial stakeholders; align deliverables to timelines.
- Create/maintain SOPs/work instructions/best practices.
Where You’ll Work
- U.S.-based remote; quarterly SF office visits or as needed.
Qualifications & Skills
- PhD or Master’s in Biostatistics/Statistics/CS/AI/Data Science (or related).
- Track A: 5+ yrs (PhD) or 7+ yrs (MS) pharma biostats; expert SAS and/or R; Python; AI/ML tool exposure (LLM APIs/prompting/automation); CDISC (SDTM/ADaM/Define-XML); NDA/BLA/MAA preferred.
- Track B: 3+ yrs AI/ML engineering; build/deploy LLM tools, RAG (LangChain/equiv), agentic workflows, MLOps; Python; working knowledge SAS/R; clinical/life sciences and GxP/21 CFR Part 11 exposure; stats fundamentals.
- All: FDA/EMA/ICH statistical/regulatory knowledge; strong communication; cross-functional collaboration; curiosity/initiative with AI.
Benefits (explicitly stated)
- Market-leading compensation; 401(k) (100% match first 3%, 50% next 2%); employee stock purchase program; pre-tax commuter benefits; $2,500 referral award (hired referrals).
- 100% premium-covered health care for you/dependents; Spring Health mental support; unlimited PTO; paid parental leave (4 months birthing, 2 months non-birthing); flex spending + group term life & disability; subsidized office lunch; hybrid flexibility; salary range (CA): $173,800–$217,000 USD.
- Deliver high-quality statistical analyses and design/build/embed AI/ML interfaces into biometrics workflows.
- Serve as primary internal resource for setting up, validating, and governing AI tooling in a GxP-compliant environment.
- Bridge pharmaceutical statistical science and applied AI engineering; manage CRO statisticians/programmers.
Responsibilities
- Pharmaceutical Biostatistics
- Apply statistical methods for medical insights, value demonstration, safety monitoring, lifecycle management.
- Support Phase II–IV clinical trial design/analysis/reporting (adaptive designs, Bayesian methods, estimands under ICH E9(R1)).
- Lead/co-lead statistics for NDA/BLA/MAA and respond to health authority queries.
- AI Interface Setup & Implementation
- Build AI/ML interface environments (SAS/R/Python with LLM APIs, RAG pipelines, clinical repositories).
- Develop AI tools (SAP drafting, TFL automation, anomaly detection, protocol deviation ID, regulatory support).
- Implement MLOps pipelines for GxP audit-ready model development/validation/deployment/monitoring.
- Apply AI governance (SHAP/XAI, bias assessment, 21 CFR Part 11/EU Annex 11 documentation).
- Automate CDISC mapping, data cleaning, submission package prep; integrate with EDC/CTMS/RTSM/pharmacovigilance.
- Cross-Functional Collaboration & CRO Oversight
- Translate stats/AI concepts for medical/regulatory/commercial stakeholders; align deliverables to timelines.
- Create/maintain SOPs/work instructions/best practices.
Where You’ll Work
- U.S.-based remote; quarterly SF office visits or as needed.
Qualifications & Skills
- PhD or Master’s in Biostatistics/Statistics/CS/AI/Data Science (or related).
- Track A: 5+ yrs (PhD) or 7+ yrs (MS) pharma biostats; expert SAS and/or R; Python; AI/ML tool exposure (LLM APIs/prompting/automation); CDISC (SDTM/ADaM/Define-XML); NDA/BLA/MAA preferred.
- Track B: 3+ yrs AI/ML engineering; build/deploy LLM tools, RAG (LangChain/equiv), agentic workflows, MLOps; Python; working knowledge SAS/R; clinical/life sciences and GxP/21 CFR Part 11 exposure; stats fundamentals.
- All: FDA/EMA/ICH statistical/regulatory knowledge; strong communication; cross-functional collaboration; curiosity/initiative with AI.
Benefits (explicitly stated)
- Market-leading compensation; 401(k) (100% match first 3%, 50% next 2%); employee stock purchase program; pre-tax commuter benefits; $2,500 referral award (hired referrals).
- 100% premium-covered health care for you/dependents; Spring Health mental support; unlimited PTO; paid parental leave (4 months birthing, 2 months non-birthing); flex spending + group term life & disability; subsidized office lunch; hybrid flexibility; salary range (CA): $173,800–$217,000 USD.