Senior Biostatistician

Hill Research; Boston (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Equity package

Comprehensive benefits

Competitive compensation

Job summary

Hill Research in Boston seeks an experienced Senior Biostatistician to own statistical thinking end-to-end for clinical trials, from design to interpretation. You will author deliverables and defend methods against regulatory expectations, often collaborating with AI and software engineers to bring TriClick™ to bear on real programs.

You’ll contribute to SDTM/ADaM workflows, code reviews, and the delivery of high-integrity analyses in a fast-moving, AI-enabled environment.

Qualifications

• Hands-on clinical development experience as a trial statistician.
• Authorship of SAPs, analysis specifications, TLF shells, and related core documentation.
• Ability to reason through design, endpoints, estimands, missing data, and sensitivity analyses.
• Comfort with SAS or R and AI-assisted development tools.
• Familiarity with CDISC standards and regulatory expectations (FDA/EMA).

Responsibilities

• Author core statistical deliverables for Phase I-III trials (SAPs, analysis specs, TLF shells).
• Own statistical thinking behind design, endpoints, estimands, analyses, and regulatory justifications.
• Scrutinize datasets, specifications, outputs, and code for consistency and traceability before release.
• Develop and modify SAS/R code using AI-assisted tools and debug analyses.
• Collaborate daily with AI/engineers to translate statistical intent into product behavior across SDTM/ADaM pipelines.
• Apply frontline statistical judgment when using TriClick™ on live programs.

Skills

SAS/R coding

Clinical trial statistics

Regulatory knowledge

AI-assisted development

Engineering collaboration

Education

Advanced degree in quantitative field

Tools

SAS

R

CDISC ADaM

SDTM

AI tooling

Job description

We’re looking for an experienced, hands‑on Senior Biostatistician for our Boston team. This is a senior individual-contributor role for someone who owns the statistical thinking on a trial end to end, from design and endpoints through specifications, outputs, and interpretation, and who authors the deliverables rather than reviewing what others produce.

Generative AI and coding agents are part of everyday statistical work here, and your judgment is what determines whether the resulting analyses are right. Most of your collaboration will be with our AI and software engineers rather than a traditional clinical matrix, working alongside them to bring TriClick™ to bear on real clinical programs.

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 Research

• Join 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.