Senior Biostatistician

DefinedTalent

. 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 .

Posted 10/20/2026full-timeUnited StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and deliverables for clinical trials, including proficiency in SAS and R, and a solid understanding of regulatory expectations from the FDA and EMA. Capable of applying statistical judgment and AI fluency to ensure the integrity and accuracy of statistical outputs.

Highest-signal resume keywords

Statistical Analysis Plans (SAPs)SAS ProgrammingR ProgrammingCDISC Standards (ADaM, SDTM)Regulatory Compliance (FDA, EMA)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisData AnalysisStatistical JudgmentDebuggingSensitivity AnalysesEstimation MethodsAnalysis SpecificationsTLF ProductionAI-Assisted DevelopmentClinical Trial Design

Soft Skills

Critical ThinkingClear CommunicationIndependenceProblem-SolvingCan-Do Attitude

Tools & Technologies

Generative AIAI Coding AgentsStatistical SoftwareAutomation ToolsClinical Data Management Systems

Industry Keywords

Clinical DevelopmentPhase I–III TrialsNDA/BLA SubmissionsHealth Authorities InteractionStatistical Programming Workflow

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Substantial hands-on experience as a trial statistician in clinical development
An advanced degree in a quantitative field
Independence to reason through 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
Working understanding of how the protocol, SAP, analysis datasets, specifications, and final outputs connect
Skeptical, critical mindset; ability to question assumptions, follow up on inconsistencies, examine outputs closely, and identify statistically unsound results
Comfort with SAS and/or R using modern AI-assisted development tools
Statistical judgment to inspect, modify, debug, and validate AI-assisted results
AI fluency
Practical working knowledge of CDISC, especially ADaM, plus 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
Ability to investigate unfamiliar statistical, data, or technical problems and work toward practical solutions
Clear communication with engineers, clinical teams, and client stakeholders
Ability to move 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
Nice to have: experience building, specifying, or shaping statistical software, tools, or automation
Nice to have: experience in a startup or small, fast-moving team

Benefits

Comp & perks

Help redefine how biostatistics and clinical trial delivery work through AI
Work with experienced scientists and engineers from leading pharma and top tech companies, with broad scope and real autonomy over how the statistics get done
Directly shape the core product and client delivery during a period of rapid growth
Competitive compensation and equity
Comprehensive health insurance (medical, dental, vision)
401(k) retirement plan with company contribution
Generous paid time off and holidays
Opportunities for rapid professional growth in a high-impact, scaling organization
Collaborative, flat organizational culture with direct access to leadership
Professional development and training support