Senior Biostatistician — Lead Clinical Trials & Analysis

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

Job summary

Cytel is seeking a Senior Biostatistician to support or lead Phase I–IV clinical studies embedded with a client Pharmaceutical company. You will conduct ad-hoc and regulatory analyses, design studies, and prepare reports with strong collaboration across clinical and regulatory teams.

Expect to develop SAPs, contribute to study design, and ensure regulatory standards are met. You will work with internal and external partners to meet timelines and maintain high quality deliverables.

Qualifications

• Master's degree in statistics or related field; PhD strongly desired.
• 5+ years supporting clinical trials in pharma/biotech.
• Experience with CROs is strongly desired.
• Experience in sample size calculations, protocol development, SAPs, and study reports.
• Strong SAS programming skills for QC outputs; R knowledge a plus.
• Solid understanding of CDISC requirements for regulatory submissions.
• Adept at ADaM specifications generation and QC of datasets.
• Ability to build strong relationships and lead regional/global teams.
• Excellent communication; able to explain methods clearly.

Responsibilities

• Provide statistical support to clinical studies.
• Contribute to protocol development and study design discussions.
• Develop SAPs and analysis datasets; define TLG specs.
• Perform statistical analyses and interpret results.
• Prepare clinical study reports including integrated summaries.
• Communicate methodologies and implications to stakeholders.
• Follow FDA/GCP guidelines for regulatory submissions.
• Contribute to programming standards, tools, and macros.

Skills

Team leadership

Communication

Statistical programming

ADaM specs

CRO experience

Clinical trial statistics

Regulatory awareness

R programming

SAS programming

Education

Master's degree in statistics

PhD preferred

Tools

SAS

R

CDISC

ADaM

Job description

Cytel is seeking a Senior Biostatistician to support or lead Phase I–IV clinical studies embedded with a client Pharmaceutical company. You will conduct ad-hoc and regulatory analyses, design studies, and prepare reports with strong collaboration across clinical and regulatory teams.

Expect to develop SAPs, contribute to study design, and ensure regulatory standards are met. You will work with internal and external partners to meet timelines and maintain high quality deliverables.