Statistical Research Scientist
hace 3 semanas
**About Us**
Aixial Group is a leading Contract Research Organisation (CRO) dedicated to delivering efficient clinical trials. With a presence in 10 countries across 3 continents, we bring together over 1000 talented professionals committed to making a positive impact in the life sciences industry.
**Job Description**
We are seeking a highly skilled Senior Biostatistician to join our team. As a key member of our clinical studies team, you will participate in the development of working hypotheses, select statistical models, and define methodologies for clinical studies.
The ideal candidate will have a strong background in biostatistics, excellent analytical skills, and the ability to work collaboratively with physicians and researchers. Your expertise will directly impact people's lives, shaping the future of clinical research.
**Responsibilities**
- Develop 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 data consistency in collaboration with the Data Management team
- Observe the consequences on the model of variations in a local parameter
- 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
- Manage submissions to the FDA/EMA
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