Associate Director, Biostatistics & AI

📋 Description

• Deliver high-quality statistical analyses and AI interfaces.
• Design, analyze, and report Phase II–IV trials; adaptive designs.
• Lead or co-statistician on NDA/BLA/MAA submissions.
• AI interface setup: SAS/R/Python to LLM APIs, RAG pipelines.
• Maintain MLOps pipelines in a GxP-compliant, audit-ready framework.
• Stay current with FDA/EMA/ICH guidance and real-world evidence.

🎯 Requirements

• PhD or Master’s in Biostatistics, Statistics, CS, AI, or related field.
• Track A: 5+ years (PhD) or 7+ years (Master’s) pharma biostatistics.
• Expert SAS and/or R; working knowledge of Python.
• AI/ML tools exposure: LLM APIs, prompt engineering; GxP.
• CDISC SDTM/ADaM/Define-XML and regulatory submission workflows.
• Track B: 3+ years AI/ML engineering (LLMs, LangChain/RAG, MLOps).
• Strong communication and cross-functional collaboration.

🎁 Benefits

• Health: Comprehensive health care with 100% premiums covered for you and dependents.
• 401K with 100% employer match on first 3% and 50% on next 2%.
• Employee Stock Purchase Program (ESPP).
• Hybrid work model with flexible paid time off.
• Paid parental leave: 4 months for birthing, 2 months for non-birthing.
• Subsidized lunch on in-office days and pre-tax commuter benefits.