Senior Biostatistician

Astrum; Barcelona; On-site; EUR 70,000 - 95,000; Full time

Job summary

Astrum is seeking a Senior Biostatistician in Barcelona to provide statistical leadership across the clinical trial lifecycle, from protocol through regulatory documentation. You will shape endpoints, estimands, sample size, randomization, and risk-based design, collaborating with internal teams and clients.

The ideal candidate holds a university degree in statistics or biostatistics, has at least three years in clinical trial statistics, is fluent in English, and is proficient in SAS;

Qualifications

• University degree in Statistics, Mathematics, or related scientific discipline.
• 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, regulatory expectations.
• Advanced statistical expertise in mixed-effects models, imputation, adaptive designs, estimand framework.
• Proficiency in SAS is required.
• Experience with Python, R, Git, and SharePoint preferred.
• Excellent written and verbal English skills; business fluency is mandatory.

Responsibilities

• Provide statistical leadership across Phase II–IV clinical studies.
• Develop statistical strategies for trials including sample size, randomization, estimands.
• Author SAPs and review TFLs.
• Review CSPs and CSRs.
• Review programming outputs and analysis datasets.
• Present and defend statistical decisions in client meetings.

Skills

Clinical trial statistics

Statistical leadership

Biostatistics expertise

English communication

Education

Master's or PhD in Statistics/Mathematics/Biostatistics

University degree requirement

Tools

SAS

Python

R

Git

SharePoint

Job description

As a Senior Biostatistician you will provide statistical leadership throughout the clinical trial lifecycle—from protocol development and study design through analysis, interpretation, and regulatory documentation. For assigned studies, you will shape the statistical strategy, including endpoints, estimands, sample size, randomization, and risk-based design, while serving as a trusted partner to internal teams and clients. This role combines technical expertise, client engagement, and strategic thinking, with a direct impact on clinical development decisions.

Key Responsibilities

• Provide statistical leadership across Phase II–IV clinical studies.
• Develop statistical and analytical strategies for clinical trials, including:
  • Sample size calculations
  • Randomization strategies
  • Estimand definitions
• Author Statistical Analysis Plans (SAPs) and 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.

Required Qualifications

• 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.