Senior Biostatistician

Astrum; Ismaning; On-site; EUR 80,000 - 110,000; Full time

Job summary

Astrum is seeking a Senior Biostatistician to provide statistical leadership across the clinical trial lifecycle, guiding design, analysis, and regulatory documentation. You will shape statistical strategy for assigned studies and collaborate with internal teams and clients to influence development decisions.

The role requires advanced statistics expertise, SAS proficiency, and strong English communication. Prior experience with SAPs, CSPs, CSRs, and TFLs is essential for success.

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, 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 strategies including sample size calculations, randomization, and estimand definitions.
• Author SAPs and review TFLs.
• Review CSPs and CSRs.
• Review and approve programming specifications and analysis datasets.
• Present and defend statistical decisions in client meetings.

Skills

Statistical expertise

English fluency

Regulatory knowledge

Education

University degree in Statistics or related field

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.