Senior Biostatistician

What You’ll Do: Author the core statistical deliverables for Phase I-III trials: Statistical Analysis Plans, analysis specifications, TLF shells, and the documentation that carries a study from protocol to final outputs Own the statistical thinking behind design, endpoints, estimands, analysis methods, missing data, and sensitivity analyses, and defend those choices against regulatory expectations Scrutinize analysis datasets, specifications, outputs, and code, including AI-generated work, for statistical sense, consistency, and traceability before anything ships Use generative AI and coding agents day to day to write and modify SAS or R code, investigate unfamiliar problems, debug, and iterate toward working analyses, while staying accountable for whether the implementation is correct Collaborate day to day with our AI and software engineers, translating statistical intent into product behavior, pressure-testing what the models and pipelines produce, and covering the ground from SDTM and ADaM through TLF production rather than working inside a statistician silo Bring frontline statistical judgment into TriClick™ by using it on live clinical programs

What You’ll Need: Substantial hands‑on clinical development experience as a trial statistician, with an advanced degree in a quantitative field and the demonstrated independence to reason through design, endpoints, estimands, methods, missing data, sensitivity analyses, and interpretation Personal authorship of major statistical deliverables (SAPs, analysis specifications, TLF shells, and related core documentation), with a working understanding of how protocol, SAP, analysis datasets and specifications, and final outputs fit together. This is a must‑have; having reviewed or approved work produced by others is not a substitute A critical, skeptical mindset: you question assumptions, chase inconsistencies, scrutinize outputs, and recognize when a result does not make statistical sense. You don’t trust code, software output, or AI-generated work simply because it ran Comfortable working with statistical code in SAS and/or R using modern AI-assisted development tools, with the statistical judgment needed to inspect, modify, debug, and validate the resulting analyses. AI fluency is a requirement at Hill, not a nice-to-have, though we are not looking for an ML engineer or AI architect Practical working knowledge of CDISC, particularly ADaM, with familiarity with SDTM and the broader clinical data and statistical programming workflow Sound understanding of regulatory expectations (FDA, EMA) for statistical analyses and deliverables, which matters more to us than having personally led a submission High autonomy and a can‑do instinct: faced with an unfamiliar statistical, data, or technical problem, you investigate it, form an informed view, and work toward a practical solution rather than treating it as someone else’s remit A clear communicator who works effectively with engineers as well as clinical and client stakeholders, moving easily between methodology, specifications, data, outputs, and AI tooling

Nice to Have: Exposure to NDA/BLA submissions or direct interaction with the FDA or other health authorities Experience building, specifying, or shaping statistical software, tooling, or automation Experience in a startup or other small, fast‑moving team where scope is set by the problem, not the job title

Why Join: Hill ResearchJoin a company redefining how biostatistics and clinical trial delivery work through AI Work alongside seasoned scientists and engineers from leading pharma and top tech, with broad scope and real autonomy over how the statistics get done Directly shape our core product (TriClick™) and client delivery during rapid growth Competitive compensation and equity package, with comprehensive benefits This role reports to the Head of Biostatistics.