Sr. Biostatistician M

Aixial Group; Madrid; Presencial; EUR 45.000 - 70.000; Jornada completa

Descripción de la vacante

Aixial Group is seeking a Senior Biostatistician to join their dynamic team in Madrid. The role involves developing statistical models for clinical studies, writing reports, and managing submissions to health authorities. Candidates should have a solid background in biostatistics and experience in clinical research, contributing directly to impactful medical advancements.

Formación

• Experience in clinical research methodology.
• Proficiency in statistical modeling.
• Strong analytical skills and problem-solving abilities.

Responsabilidades

• Develop working hypotheses and select statistical methodologies.
• Write statistical sections of study reports and present results.
• Manage FDA/EMA submissions and validate data consistency.

Conocimientos

Statistical analysis

Clinical research

Data validation

Educación

Master's in Biostatistics or related field

Descripción del empleo

You are a highly skilled professional with a 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's 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 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 (Food and Drug Administration) / EMA (European Medicines Agency).

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