Senior Biostatistician – Europe

Excelya>All job opportunites>Full-time, Permanent Contract>Senior Biostatistician – Europe

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

To learn more about us, visit

Excelya is seeking to hire a Sr. Biostatistician based in the European Union, the role is remote and will participate in exciting projects dedicated to a global pharmaceutical company.

Responsibilities :

  • Establish the sample size for the study and possibly develop simulation programs to assess the operational characteristics of a trial.
  • Collaborate with the team on how to collect and derive data.
  • Review and contribute to study documents: Case Report From (CRF), Central monitoring Plan (CMP), Study Risk Management Plan, IRT specifications….
  • Provide statistical expertise in data review
  • Determine the randomisation scheme and ensure that it is carried out correctly by the IRT
  • Write an accurate, clear and complete statistical analysis plan (SAP) with the most appropriate methodology and data presentation. Build the list of statistical appendices for the study.
  • Provide programming instructions to statistical programmers, validation of SDTM/ADAM documentation (mainly derived variables).
  • Prepare, check and approve statistical analysis programs.
  • Communicating, discussing and interpreting statistical results, including the joint development of the clinical study report.
  • Participation in submission activities.
  • Work in accordance with ICH-GCP

Requirements :

  • You have a master’s degree in statistics, or mathematics with focus on statistics
  • 7+ years of experience on clinical trials
  • Good knowledge of statistical method CDISC or SDTM/ADAM
  • Experience in oncology studies
  • Good knowledge of SAS and R programming languages
  • Fluent in English
  • Good communication skills and team spirit



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