Lead Biostatistician: Clinical Trial Strategy & Analysis

Astrum CRO; Matosinhos; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Astrum CRO is seeking a Senior Biostatistician to provide statistical leadership across Phase II–IV clinical studies in Portugal. You will shape the statistical strategy, endpoints, estimands, and sample size, partnering with internal teams and clients.

You will author SAPs, review CSRs and TFLs, ensure regulatory compliance with GCP and CDISC standards, and present statistical decisions in client meetings. Fluency in English is required.

Qualifications

• University degree in Statistics, Mathematics, or related quantitative/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, and regulatory expectations.
• Advanced statistical expertise in mixed-effects regression, multiple imputation, adaptive designs, and/or 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.

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 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.

Skills

Mixed-effects models

Multiple imputation

Adaptive designs

Estimand framework

SAS

Education

University degree in Statistics/Mathematics or related field

Tools

Python

R

Git

SharePoint

Job description

Astrum CRO is seeking a Senior Biostatistician to provide statistical leadership across Phase II–IV clinical studies in Portugal. You will shape the statistical strategy, endpoints, estimands, and sample size, partnering with internal teams and clients.

You will author SAPs, review CSRs and TFLs, ensure regulatory compliance with GCP and CDISC standards, and present statistical decisions in client meetings. Fluency in English is required.