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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, authoring SAPs, and effectively communicating statistical decisions to stakeholders.
Highest-signal resume keywords
Statistical LeadershipStatistical Analysis Plans (SAPs)Good Clinical Practice (GCP)SAS ProficiencyClinical Trial Statistics
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 DefinitionRandomization StrategiesMixed-Effects Regression ModelsMultiple ImputationAdaptive DesignsEstimand FrameworkClinical Study Protocols (CSPs)Clinical Study Reports (CSRs)Tables, Figures, and Listings (TFLs)
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationStrategic ThinkingClient EngagementTeam Collaboration
Tools & Technologies
SASPythonRGitSharePoint
Industry Keywords
ICH E3ICH E6ICH E9CDISC StandardsRegulatory Expectations
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
- Define sample sizes, randomization strategies, and 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
- Serve as a trusted partner to internal teams and clients
- Support clinical development decisions through technical expertise, client engagement, and strategic thinking
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 areas such as 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