DefinedTalent

Clinical Research

• Write core statistical deliverables for Phase I–III trials, including Statistical Analysis Plans, analysis specifications, TLF shells, and documentation taking studies 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 daily to write and modify SAS or R code, explore unfamiliar problems, debug, and iterate to working analyses while remaining accountable for correctness
• Partner with AI and software engineers to turn statistical intent into product behavior and stress-test model and pipeline outputs
• Work across SDTM, ADaM, and TLF production rather than in a statistics silo
• Apply frontline statistical judgment to the platform by using it on live clinical programs

Explore Senior Biostatistician at DefinedTalent. Review requirements and application details.