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Sr. Biostatistician M / F

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Navarra

Presencial

EUR 40.000 - 80.000

Jornada completa

Hace 18 días

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Descripción de la vacante

An established industry player in life sciences is seeking a Senior Biostatistician to join their dynamic team. This role offers the opportunity to collaborate with physicians and clinical teams to develop statistical methodologies that directly impact clinical research outcomes. You will be responsible for crafting statistical analysis plans, validating data, and presenting findings, all while working in a stimulating international environment. If you are passionate about making a difference in people's lives through innovative research, this position is perfect for you!

Formación

  • Expertise in statistical analysis and methodology for clinical studies.
  • Experience in managing submissions to regulatory agencies like FDA and EMA.

Responsabilidades

  • Develop statistical models and methodologies for clinical research.
  • Create statistical analysis plans and validate data consistency.
  • Write statistical sections of study reports and present results.

Conocimientos

Statistical Analysis
Clinical Research
Data Validation
Statistical Methodology
FDA Submissions

Educación

Master's in Statistics
PhD in Biostatistics

Herramientas

SAS
R
SPSS

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):

  1. Participate in the development of working hypotheses in collaboration with physicians and the clinical studies team.
  2. Select a statistical model and define the statistical methodology for clinical studies.
  3. Determine the number of subjects to be studied.
  4. Create the statistical analysis plan.
  5. Participate in protocol drafting and validation.
  6. Set up randomization plans.
  7. Validate data consistency in collaboration with the Data Management team.
  8. Observe the consequences on the model of variations in a local parameter.
  9. Perform and program analyses.
  10. Write statistical sections of study reports.
  11. Present statistical results.
  12. Monitor and propose new statistical tools and methodologies through scientific and technical reading.
  13. Participate in exchanges on technical subjects with members of the research team.
  14. Manage submissions to the FDA (Food and Drug Administration) / EMA (European Medicines Agency).
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