Biostatistician

Excelya>Full-time>Biostatistician

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.

Mission

You will be involved in clinical studies (phase 1/2) on the following activities :

  • Sample size or power calculations/simulations files (eg, East/SAS/R script as applicable) and documentation (eg, report/memo/respective section in the Statistical Analysis Plan (SAP) or any study document as applicable)
  • Statistical section of any study document (eg, study ID card, protocol, study report)
  • Statistical documentation for randomization plan and User Acceptance Test reports as applicable (eg, statistical documentation and specifications for Interactive Response Technology (IRT))
  • Documentation of statistical review of study documents as applicable (eg, Case Report Form, protocol, study risk management plan, IRT specifications, study report…) or project documents as applicable
  • DMC charter statistical documentation and SAP as applicable
  • Statistical surveillance reports when applicable (or data surveillance reports as applicable)
  • SAP and list of TL&Fs (Tables, Listings and Figures) for the study (including shell TL&Fs document for study-specific outputs) or pool of studies as applicable
  • Documentation of review of SDTM/ADAM documentation (mainly derived variables)
  • Documented instructions for statistical programmers
  • Statistical Status at Study Team Meetings (eg, slides) as applicable
  • Statistical programs in SAS or R and QC documentation
  • Dry-run and final reports outputs and interpretation
  • Documentation of statistical review of publications as applicable

Profile:

  • You have a Master degree/engineering school (ENSAI, ISPED…)

  • You have at least 4 years of experience in statistics in clinical study

  • Professional English (written/oral) required

  • Home or office based positions across Europe

Summary

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