Lead Biostatistician - Clinical Trials & Analysis

Cytel; Netherlands; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel Netherlands seeks an experienced Senior Biostatistician to lead or support Phase I–IV clinical studies, embedded within a pharmaceutical client. You will perform advanced analyses, develop SAPs, and prepare integrated summaries for submissions, collaborating across clinical and regulatory teams.

You will work with SAS and R, ensure CDISC/ADaM compliance, and maintain robust programming standards while fostering strong cross-functional relationships across global teams.

Qualifications

• Bachelor's degree is required in statistics or related field.
• 5+ years of clinical trials experience in pharma/biotech or CRO.
• Experience with SAS, R, and regulatory submissions.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Provide statistical support to clinical studies.
• Participate in study protocol development and design discussions; assist with sample size calculations.
• Review CRFs and data review guidelines; develop SAPs and analysis datasets.
• Perform statistical analyses and interpret results; prepare safety and efficacy summaries.
• Prepare clinical study reports including integrated summaries for submissions and regulatory questions.
• Communicate methodology and implications clearly to stakeholders; ensure compliance with FDA/GxP guidelines.
• Contribute to standards for programming tools, outputs, and macros; collaborate with CROs and vendors.
• Assist in CRFs, edit checks, and data validation plans; may review data transfers.
• Support timely project delivery through cross-functional collaboration.

Skills

Clinical trials

SAS programming

R programming

CDISC/ADaM

Statistical analysis

Regulatory submissions

Communication skills

Team leadership

Education

Bachelor's degree in statistics or related discipline

Tools

SAS

R

ADaM standards

CDISC standards

Job description

Cytel Netherlands seeks an experienced Senior Biostatistician to lead or support Phase I–IV clinical studies, embedded within a pharmaceutical client. You will perform advanced analyses, develop SAPs, and prepare integrated summaries for submissions, collaborating across clinical and regulatory teams.

You will work with SAS and R, ensure CDISC/ADaM compliance, and maintain robust programming standards while fostering strong cross-functional relationships across global teams.