Senior Biostatistician: Lead Clinical Trial Statistics

Astrum; Matosinhos; On-site; EUR 65,000 - 90,000; Full time

Job summary

Astrum is seeking a Senior Biostatistician to provide statistical leadership throughout the clinical trial lifecycle, from design to regulatory documentation. You will shape statistical strategy for assigned studies, and act as a trusted partner to internal teams and clients.

Based in Porto, Portugal, the role requires SAS proficiency, advanced statistics expertise, and excellent English communication to support Phase II–IV trials and regulatory submissions.

Qualifications

• University degree in Statistics, Mathematics, or related quantitative 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 models, multiple imputation, adaptive designs, and 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, and estimand definitions.
• Author SAPs and review TFLs.
• Review CSPs and CSRs.
• Review and approve programming specifications, statistical outputs, and analysis datasets.
• Present and defend statistical decisions in client meetings.

Skills

SAS proficiency

GCP/ICH/E3-E9 knowledge

Estimand framework

Statistical leadership

English communication

Education

University degree in Statistics or related quantitative field

Tools

SAS

Python

R

Git

SharePoint

Job description

Astrum is seeking a Senior Biostatistician to provide statistical leadership throughout the clinical trial lifecycle, from design to regulatory documentation. You will shape statistical strategy for assigned studies, and act as a trusted partner to internal teams and clients.

Based in Porto, Portugal, the role requires SAS proficiency, advanced statistics expertise, and excellent English communication to support Phase II–IV trials and regulatory submissions.