Senior Biostatistician

Sr. Biostatistician

DefinedTalent is looking for a Sr. Biostatistician to join one of their clients that is transforming clinical data workflows with multi agent ai and automation; cutting cycle times, reducing cost and ensuring compliance. This is a senior individual-contributor role. You'll own the statistical thinking on trials from start to finish, covering design, endpoints, specifications, outputs, and interpretation. You'll write the deliverables yourself rather than review work others produce.

Generative AI and coding agents are part of daily statistical work here, and your judgment decides whether the resulting analyses are correct. Instead of a traditional clinical matrix, you'll work mostly with our AI and software engineers, applying our AI-driven biostatistics platform to real clinical programs.

Responsibilities: Write the core statistical deliverables for Phase I–III trials, including Statistical Analysis Plans, analysis specifications, TLF shells, and the documentation that takes a study from protocol to final outputs

Own decisions on design, endpoints, estimands, analysis methods, missing data, and sensitivity analyses, and justify them against regulatory expectations

Review analysis datasets, specifications, outputs, and code, including AI-generated work, for statistical soundness, consistency, and traceability before release

Use generative AI and coding agents every day to write and modify SAS or R code, explore unfamiliar problems, debug, and iterate to working analyses, while staying accountable for the correctness of the implementation

Partner closely with AI and software engineers to turn statistical intent into product behavior and stress-test what models and pipelines produce, working across SDTM, ADaM, and TLF production rather than in a statistics silo

Apply frontline statistical judgment to our platform by using it on live clinical programs