Biostatistician – France

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.

What we offer:

Contribute to the set-up and monitoring of clinical trials in collaboration with the project statistician and the clinical trial team: 

* Sample size or power calculations/simulations files (eg, East/SAS/R script as applicable) and documentation 

* Statistical section of any study document 

* Statistical documentation for randomization plan and User Acceptance Test reports

* Documentation of statistical review of study documents 

* DMC charter statistical documentation and SAP 

* Statistical surveillance reports 

* SAP and list of TL&Fs (Tables, Listings and Figures) for the study

* Documentation of review of SDTM/ADAM documentation 

* Statistical programs in SAS or R and QC documentation



Minimum Requirements :

  • Degree in a relevant field such as statistics, computer sciences, etc.
  • Experience as a Biostatistician within a biotech, CRO or pharmaceutical company
  • Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs
  • Proven professional experience with SDTMs, ADaM datasets and TFLs
  • Prior experience working with oncology data (safety and efficacy) is preferred
  • Ability to effectively communicate statistical concepts
  • Business fluency in English

The position is based in France (remote)



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