Senior Real World Evidence Statistician

Senior Real World Evidence Statistician (H/F)

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 withregulatory 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 keepabreast 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 fileds.
• 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
• Englishfluency is required