Senior Biostatistician

Cornerstone International Clinical; München; On-site; EUR 90,000 - 125,000; Full time

Job summary

Cornerstone International Clinical in Munich, Germany, is seeking a Senior Biostatistician to lead the statistical aspects of clinical research programmes, from study design through to final reporting. You will collaborate with clinical, data management and regulatory teams to produce analyses that meet the highest scientific standards.

The role requires an MSc or PhD in statistics or biostatistics, a minimum of four years in biostatistics for clinical research, and proficiency in SAS with R

Qualifications

• MSc or PhD in statistics, biostatistics, or a related quantitative field.
• Minimum four years of biostatistics experience in clinical research.
• Proficiency in SAS; R skills desirable.
• Strong communication and ability to present findings to non-statistical audiences.

Responsibilities

• Lead statistical input across Phase I to IV studies.
• Author and review analysis plans, randomisation specs, and programming shells.
• Produce and QC tables, listings, and figures for reports.
• Provide input to protocol design, sample size calculations, and adaptive designs.
• Liaise with regulatory agencies on statistical methodology as required.
• Contribute to quality review of statistical deliverables.

Skills

Biostatistics

Clinical trials

SAS

R programming

Statistical analysis

Communication

Education

MSc or PhD in statistics/biostatistics

Tools

SAS

R

Job description

We are looking for a Senior Biostatistician to lead the statistical aspects of clinical research programmes, from study design through to final reporting. You will work closely with clinical, data management and regulatory teams to produce analyses that meet the highest scientific standards.

Responsibilities

• Lead statistical input across Phase I to IV clinical studies
• Author and review statistical analysis plans, randomisation specifications and programming shells
• Produce and QC TLFs (tables, listings, figures) for clinical study reports
• Provide statistical input to protocol design, sample size calculations and adaptive design elements
• Liaise with regulatory agencies on statistical methodology as required
• Contribute to quality review of statistical deliverables across the team

Requirements

• MSc or PhD in statistics, biostatistics or a closely related quantitative discipline
• Minimum four years of biostatistics experience in clinical research
• Proficiency in SAS; R skills desirable
• Strong communication skills and ability to present statistical findings to non-statistical audiences