Gif-sur-Yvertte, France.
As a senior RWE statistician, you join an international and committed team, in charge of methodological and statistical approaches serving our real-world data studies and supporting related development plans.
You drive the RWD studies you are assigned, ensuring state-of-the-art methodologies and deliverables, in compliance with regulatory guidelines as well as all Servier policies and procedures.
Main responsibilities:
- Collaborates in the preparation of the RWD study protocol: methodological choices, statistical estimation of the number of patients and statistical analysis strategy.
- Develop, implement or advise on appropriate new statistical methodologies and keep abreast of current issues and developments in statistical innovation with RWE applications.
- Ensures RWE data statistical analysis:
- Contributes to statistical methodology definition for study designs
- Writes the Statistical Analysis Plan (SAP), the table/listings/graph document (TLG),
- Perform data analyses for real-world datasets
- Ensures validation of the results produced and their validity and robustness,
- Participates in internal communication of results,
- Review the study report and ensures proper statistical interpretation of the results
- Collaborates with multi-disciplinary project teams to establish project goals and timelines.
- Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWD.
- Contributes to productive collaborations with other stakeholders, promoting teamwork, quality, operational efficiency and innovation
- Lead or participates in working groups on methodological and statistical issues, as well as in transversal and multidisciplinary projects
- Contributes to the internal and external visibility of the department and promote the development of internal scientific knowledge.
Profile:
- Master or Doctoral degree or equivalents in Biostatistics, Statistics or closely related fields.
- 5 years’ experience as statistician for real-world data studies
- Strong knowledge of real-world study methodologies
- Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries.
- Mastery of regulatory guidelines (FDA, EMEA, ICH)
- R expertise
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- English fluency is required
This job is posted by Servier.
This link brings you to the website of Servier.
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