Senior Biostatistician

DefinedTalent • Princeton, NJ

3d

About The Position

DefinedTalent is seeking a Senior Biostatistician for a client transforming clinical data workflows through multi-agent AI and automation. This is a senior individual-contributor role focused on owning statistical work for clinical trials from design through final outputs. The biostatistician will personally author statistical deliverables and make and justify decisions about trial design, endpoints, estimands, analysis methods, missing data, sensitivity analyses, and interpretation in line with regulatory expectations.

The role uses generative AI and coding agents as part of daily statistical work. The biostatistician is accountable for evaluating and validating AI-assisted analyses and code. Rather than working primarily within a traditional clinical matrix, the role partners closely with AI and software engineers and applies an AI-driven biostatistics platform to live clinical programs. It spans SDTM, ADaM, and TLF production and includes influencing both the platform and client delivery.

Requirements

• Substantial hands-on experience as a trial statistician in clinical development.
• An advanced degree in a quantitative field.
• Independence in reasoning through trial design, endpoints, estimands, methods, missing data, sensitivity analyses, and interpretation.
• Personal authorship of major statistical deliverables, including SAPs, analysis specifications, TLF shells, and related documentation; reviewing or approving others’ work is not a substitute.
• Working understanding of how the protocol, SAP, analysis datasets, specifications, and final outputs connect.
• A skeptical, critical mindset: question assumptions, investigate inconsistencies, examine outputs closely, and do not trust code, software output, or AI-generated work without scrutiny.
• Comfort with SAS and/or R using modern AI-assisted development tools, and the judgment 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 grasp of FDA and EMA expectations for statistical analyses and deliverables.
• High autonomy and a can-do attitude, including the ability to investigate unfamiliar statistical, data, or technical problems and work toward practical solutions.
• Clear communication with engineers, clinical teams, and client stakeholders, and ability to move between methodology, specifications, data, outputs, and AI tooling.

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 where the problem defines the scope rather than the job title.

Responsibilities

• Author core statistical deliverables for Phase I–III trials, including Statistical Analysis Plans, analysis specifications, TLF shells, and documentation connecting the protocol to final outputs.
• Own and justify decisions about trial design, endpoints, estimands, analysis methods, missing data, and sensitivity analyses 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, investigate unfamiliar problems, debug, and iterate toward working analyses while remaining accountable for 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 rather than in a statistics silo.
• Apply statistical judgment to the platform by using it on live clinical programs.

Benefits

• Competitive compensation and equity.
• Comprehensive health insurance, including medical, dental, and vision.
• 401(k) retirement plan with company contribution.
• Generous paid time off and holidays.
• Professional development and training support.
• Opportunities for rapid professional growth in a high-impact, scaling organization.
• Collaborative, flat organizational culture with direct access to leadership.
• Broad scope and autonomy, with the opportunity to shape the core product and client delivery.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior