Senior Biostatistician: Clinical Trials & Regulatory

Cytel; Abla; Remote; EUR 70,000 - 90,000; Full time

Job summary

Cytel is seeking a Senior Biostatistician to support or lead analyses across phase I–IV clinical studies. You will apply advanced statistical methods, review CRFs and SAPs, and collaborate with CROs and clients. Strong communication and regulatory submission experience are essential.

You will drive study design discussions, perform sample size calculations, and prepare ASR/CSR components, ensuring adherence to FDA/ICH guidelines and CDISC standards.

Qualifications

• Bachelor's degree in statistics or related discipline.
• 5+ years supporting clinical trials in pharma or biotech.
• Experience with regulatory submissions and data standards.

Responsibilities

• Provide statistical support for clinical studies.
• Develop SAPs, study design discussions and sample size calculations.
• Review CRFs and data review guidelines; create analysis datasets and TLG specs.
• Perform statistical analyses and interpret results for submissions.
• Prepare clinical study reports including integrated summaries.
• Communicate methodology and decisions clearly to teams.

Skills

Communication

Regulatory experience

Sample size calculation

CDISC/ADaM

Education

Bachelor's degree in statistics

Tools

SAS

R

Job description

Cytel is seeking a Senior Biostatistician to support or lead analyses across phase I–IV clinical studies. You will apply advanced statistical methods, review CRFs and SAPs, and collaborate with CROs and clients. Strong communication and regulatory submission experience are essential.

You will drive study design discussions, perform sample size calculations, and prepare ASR/CSR components, ensuring adherence to FDA/ICH guidelines and CDISC standards.