Senior Biostatistician

DefinedTalent•Princeton, NJ

About The Position

DefinedTalent is seeking a Senior Biostatistician for a client transforming clinical data workflows with multi-agent AI and automation. This senior individual-contributor role owns statistical thinking across clinical trials from design through interpretation. The biostatistician personally authors key statistical deliverables and works primarily with AI and software engineers, using an AI-driven biostatistics platform on live clinical programs rather than working in a traditional clinical matrix. Generative AI and coding agents are part of daily statistical work. The role requires evaluating and validating AI-generated analyses and code, and retaining accountability for statistical and implementation correctness. The biostatistician will help shape the platform and client delivery while working across SDTM, ADaM, and TLF production. The position calls for substantial hands-on trial-statistician experience in clinical development, an advanced degree in a quantitative field, strong knowledge of regulatory expectations, and the autonomy to reason through statistical and technical problems. Compensation includes equity and comprehensive benefits.

Requirements

Substantial hands-on experience as a trial statistician in clinical development.
An advanced degree in a quantitative field.
Personal authorship of major statistical deliverables, including SAPs, analysis specifications, TLF shells, and related documentation; review or approval of others’ work is not a substitute.
Working understanding of how the protocol, SAP, analysis datasets, specifications, and final outputs connect.
Ability to independently reason through trial design, endpoints, estimands, analysis methods, missing data, sensitivity analyses, and interpretation.
A skeptical, critical mindset and ability to examine assumptions, inconsistencies, outputs, and AI-generated work rather than trusting results simply because code ran.
Comfort with SAS and/or R and modern AI-assisted development tools, with the ability to inspect, modify, debug, and validate results; AI fluency is required.
Practical working knowledge of CDISC, especially ADaM, and familiarity with SDTM and the broader clinical data and statistical programming workflow.
Solid understanding of FDA and EMA expectations for statistical analyses and deliverables.
High autonomy and a can-do attitude when addressing unfamiliar statistical, data, or technical problems.
Clear communication with engineers, clinical teams, and client stakeholders.

Nice To Haves

Exposure to NDA/BLA submissions or direct interaction with the FDA or other health authorities.
Experience building, specifying, or shaping statistical software, tools, or automation.
Experience in a startup or small, fast-moving team.

Responsibilities

Author core statistical deliverables for Phase I–III trials, including Statistical Analysis Plans, analysis specifications, TLF shells, and related documentation from protocol through final outputs.
Make and justify decisions about trial design, endpoints, estimands, analysis methods, missing data, and sensitivity analyses in light of 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 to write and modify SAS or R code, investigate unfamiliar problems, debug, and develop working analyses; remain accountable for implementation correctness.
Partner with AI and software engineers to translate statistical intent into product behavior and stress-test model and pipeline outputs.
Work across SDTM, ADaM, and TLF production, applying the platform to live clinical programs.
Communicate and collaborate with engineers, clinical teams, and client stakeholders, moving between methodology, specifications, data, outputs, and AI tooling.
Investigate unfamiliar statistical, data, or technical problems and pursue practical solutions independently.