Principal Biostatistician FSP

Principal Biostatistician FSP

Cytel

Remote, France

Responsibilities

Main Responsibilities:

• Standardize exploratory endpoint and biomarker data following CDISC standards (SDTM, ADaM) to enable integrated translational analyses;
• Execute translational statistical activities for exploratory endpoints under the supervision of translational study statistician;
• Develop, validate, and maintain analysis datasets and statistical outputs (TLFs) under the supervision of a translational biostatistician;
• Perform statistical analyses to support translational research, including assay characterization, concordance evaluation, sample selection, and exploratory endpoint data analysis;
• Implement reproducible data workflows and automate analytical pipelines using R and related tools;
• Apply advanced statistical methods (e.g., mixed models, ROC/Youden index, classification, or concordance analysis) to characterize exploratory endpoints;
• Contribute to the development of interactive visualization tools (e.g., R Shiny apps) for cross-study data exploration.

Qualifications

Requirements:

• Ph.D. or Master’s degree (with 3-5 years’ experience) in Statistics, Biostatistics, Bioinformatics, or a closely related quantitative discipline;
• Strong proficiency in R programming, including data wrangling, statistical modeling, and visualization;
• Solid foundation in statistical inference, experimental design, and data interpretation;
• Familiarity with CDISC formats (SDTM, ADaM) and regulatory data standards;
• Knowledge of clinical data management systems preferred (e.g. eWISE environment);
• Experience or interest in large-scale omics data applications (e.g., transcriptomic or proteomic);
• Experience with Shiny app development or other interactive data visualization tools is a plus;
• Excellent communication and documentation skills in English, with the ability to clearly convey statistical results to interdisciplinary teams;
• Maintain up-to-date knowledge of biostatistical and computational techniques relevant to translational medicine and ensure compliance with internal standards and regulatory expectations;
• Soft skills: team spirit, adaptation, flexibility, agility.