Aixial Group, CRO (Clinical Research Organization), specialized in Life Sciences. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.
Since 2014, we have been part of the Alten family. We are developing our activities in France, Belgium, Switzerland, Czech Republic, Denmark, UK, US…with even more prospects for expanding internationally.
Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,… industriesin clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR…activities.
Aixial Group continues to grow, and to recruit in the clinical trial professions. Come and join us, and discover our website to follow the news of our offers: https://www.aixialgroup.com/join-us/
For more information: https://www.linkedin.com/company/aixialgroup/about/
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)
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 10 years experience as a Biostatistician in clinical trials in CROs (Contract Research Organizations) and/or pharmaceutical laboratories
You are familiar with CDISC and/or SDTM standards.
Knowlege of SAS programming and R would be a plus
Experience in early and/or late phase would be a plus
You have ideally a previous experience in oncologie and/or diabetes
Able to carry out complex tasks within defined deadlines, you are rigorous and organized.
Ability to work with multidisciplinary teams
Languages required: Fluent English, French would be a plus
Position to be filled remotely in the European Union