Associate Director, Biostatistics & AI

What You’ll Do

The Associate Director, Biostatistics & AI is a senior individual contributor and emerging people leader responsible for the delivery of high-quality statistical analyses and for designing, building, and embedding AI/ML interfaces into the day-to-day workflows of the biometrics function. This role sits at the intersection of pharmaceutical statistical science and applied AI engineering — and is the primary internal resource for setting up, validating, and governing AI tooling in a GxP-compliant environment.

A successful candidate will bring either deep pharmaceutical biometrics expertise with growing AI/ML skills, or strong AI/ML engineering experience with meaningful exposure to clinical or life sciences data. In either case, they will have the drive and aptitude to rapidly bridge both domains. They will work across cross-functional teams including Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance, and will manage CRO statisticians and programmers on assigned programs.

Responsibilities

• Pharmaceutical Biostatistics
  • Apply appropriate statistical methodologies supporting 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)
  • Contribute to NDA, BLA, MAA, and other global regulatory submissions as lead or co-statistician; support responses to health authority queries
  • Stay current with FDA, EMA, and ICH guidance on statistical methodology, and real-world evidence (RWE)
• AI Interface Setup & Implementation