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Tj513 - Sr. Biostatistician M/F

hace 2 meses

Madrid, España Aixial Group A tiempo completo

Sr. Biostatistician M / F

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)

Hace 20 días
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