Senior Biostatistician — Lead Clinical Trial Analytics

Cytel; Abla; On-site; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior Biostatistician to support or lead Phase I–IV clinical studies embedded with a pharmaceutical client, backed by Cytel’s expertise.

You will drive statistical analyses, contribute to study design, and ensure high-quality outputs in collaboration with cross-functional teams. Responsibilities include SAP development, regulatory submissions support, data review, and effective communication of statistical methods, with a strong emphasis on FDA guidance and CDISC

Qualifications

• Master’s degree in statistics or related discipline.
• Ph.D. strongly desired.
• 5+ years supporting clinical trials in Pharma or Biotechnology.

Responsibilities

• Providing statistical support to clinical studies.
• Participating in study design discussions and sample size calculations.
• Reviewing CRFs and SAPs; developing analysis datasets and TLG specifications.
• Performing statistical analyses and interpreting results.
• Preparing clinical study reports, including integrated summaries for submissions.
• Communicating methodology and implications of decisions clearly.
• Understand and follow FDA regulations and GCP for electronic submissions.
• Contribute to the creation, maintenance, and validation of programming standards.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide review and/or author data transfer specifications for external vendor data.
• Collaborate with CROs, software vendors, and clinical development partners to meet timelines.
• Provide review and/or author SOPs and Work Instructions for statistical programming practices.

Skills

Statistical analysis

CDISC/ADaM knowledge

Regulatory submissions understanding

Communication skills

Education

Master’s degree in statistics or related field

Ph.D. strongly desired

Tools

SAS

R

Job description

Cytel Inc. is seeking a Senior Biostatistician to support or lead Phase I–IV clinical studies embedded with a pharmaceutical client, backed by Cytel’s expertise.

You will drive statistical analyses, contribute to study design, and ensure high-quality outputs in collaboration with cross-functional teams. Responsibilities include SAP development, regulatory submissions support, data review, and effective communication of statistical methods, with a strong emphasis on FDA guidance and CDISC