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Astrum

Senior Biostatistician

Astrum

. Provide statistical leadership across Phase II–IV clinical studies .

Posted 10/31/2026full-timeMatosinhos • PortugalSeniorWebsite

Core Competencies

Role fit
Core Competencies

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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 like Statistical Analysis Plans and Clinical Study Reports.

Highest-signal resume keywords
Statistical LeadershipStatistical Analysis Plans (SAPs)GCP KnowledgeSAS ProficiencyClinical Trial Statistics

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Statistical AnalysisSample Size CalculationMixed-Effects Regression ModelsMultiple ImputationAdaptive DesignsEstimand FrameworkRandomization StrategiesStatistical ProgrammingData AnalysisClinical Trial Design
Soft Skills
Excellent Written CommunicationExcellent Verbal Communication
Tools & Technologies
SASPythonRGitSharePoint
Industry Keywords
Clinical StudiesICH E3ICH E6ICH E9CDISC StandardsClinical Study Protocols (CSPs)Clinical Study Reports (CSRs)Tables, Figures, and Listings (TFLs)Regulatory DocumentationBiostatistics

Tech Stack

Tools & technologies
Google 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 from protocol development and study design through analysis, interpretation, and regulatory documentation
  • Partner with internal teams and clients on clinical development decisions

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