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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced statistical expertise in clinical trial design and analysis, including proficiency in SAS and familiarity with regulatory standards such as GCP and ICH. Capable of developing statistical strategies and authoring key documentation throughout the clinical trial lifecycle.
Highest-signal resume keywords
Statistical LeadershipStatistical Analysis Plans (SAPs)Clinical Study Protocols (CSPs)SAS ProficiencyGCP and ICH Standards
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical AnalysisSample Size CalculationMixed-Effects Regression ModelsMultiple ImputationAdaptive DesignsEstimand Framework
Soft Skills
Excellent Written CommunicationExcellent Verbal Communication
Tools & Technologies
SASPythonRGitSharePoint
Industry Keywords
Clinical TrialsRegulatory DocumentationCDISC StandardsStatistical OutputsClinical Study Reports (CSRs)
Tech Stack
Tools & technologiesGoogle Cloud PlatformPython
About the role
Key responsibilities & impact- Provide statistical leadership across Phase II–IV clinical studies
- Develop statistical and analytical strategies for clinical trials
- Perform sample size calculations
- Develop randomization strategies
- Define estimands
- Author Statistical Analysis Plans (SAPs)
- Review tables, figures, and listings (TFLs)
- Review Clinical Study Protocols (CSPs) and Clinical Study Reports (CSRs)
- Review and approve programming specifications, statistical outputs, and analysis datasets prepared by statistical programmers
- Present and defend statistical decisions in client meetings
- Shape statistical strategy throughout the clinical trial lifecycle, from protocol development and study design through analysis, interpretation, and regulatory documentation
- Serve as a trusted partner to internal teams and clients
Requirements
What you’ll need- University degree in Statistics, Mathematics, or a related quantitative or scientific discipline, such as Physics, Chemistry, Biostatistics, or Epidemiology
- At least three years of experience in clinical trial statistics
- Experience developing or reviewing SAPs, CSPs, CSRs, and TFLs
- Working knowledge of GCP, ICH E3/E6/E9, CDISC standards, and regulatory expectations
- Advanced statistical expertise in mixed-effects regression models, multiple imputation, adaptive designs, and/or the estimand framework
- Proficiency in SAS is required
- Experience with Python, R, Git, and SharePoint is preferred
- Excellent written and verbal English skills; business fluency is mandatory
Benefits
Comp & perks- Permanent employment
- Full-time employment
- Hybrid work arrangement