Sr. Biostatistician - M/F

Description du poste et des missions

You are a highly skilled professional with passion for the world of life sciences and clinical research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives? Come and join Aixial Group to contribute to shaping the future of clinical research!

We are currently looking for a Senior Biostatistician M/F to carry out the following tasks (non-exhaustive list):

• Participate in the development of working hypotheses in collaboration with physicians and the clinical studies team.


• Select a statistical model and define the statistical methodology for clinical studies


• Determine the number of subjects to be studied


• Create the statistical analysis plan


• Participate in protocol drafting and validation


• Set up randomization plans


• Validate evaluation criteria


• Validate data consistency in collaboration with the Data Management team


• Observe the consequences on the model of variations in a local parameter


• Produce data reviews


• Perform and program analyses


• Write statistical sections of study reports


• Present statistical results


• Monitor and propose new statistical tools and methodologies through scientific and technical reading.


• Participate in exchanges on technical subjects with members of the research team.


• Complete Risk Management Plan


• Manage submissions to the FDA (Food and Drug Administration/EMA (European Medicines Agency)

Profil souhaité

Your profile :

• You have a BAC+5 or PhD in statistics, applied mathematics, computer science or other equivalent field of study.


• You have at least 5 years experience as a Biostatistician in clinical trials in CROs (Contract Research Organizations) and/or pharmaceutical laboratories


• You have experience in early and late phase


• You have experience in Immuno Inflammatory


• You are familiar with CDISC and/or SDTM standards.


• Knowlege of SAS programming and R would be a plus


• You have ideally a previous experience in immunology and inflammation


• Able to carry out complex tasks within defined deadlines, you are rigorous and organized


• Experience in phases 2 and 3 of clinical trials would be appreciated


• Ability to work with multidisciplinary teams


• Languages required: Fluent English, French would be a plus


• Position to be filled remotely in the European Union

Informations du recruteur

Lieu de la mission