Principal Biostatistician

Responsibilities :

• Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
• Lead large projects involving complex project dynamics and ensuring alignment with strategic goals.
• Oversee data analysis initiatives; develop new methodologies and tools for data management.
• Participate in meetings with internal and external stakeholders in the discussion / defense of new study designs, contributing with data science expertise.
• Participate and oversee the development of Study Protocols by providing statistical input and data specifications.
• Design and oversee eCRF design and structure to ensure that it meets the specific requirements defined in the study protocol.
• Develop and / or oversee the Data Science Plan for assigned projects.
• Define or review randomization procedures and produce randomization lists.
• Develop and review Statistical Analysis Plans.
• Perform and / or supervise programming of tables, listings, figures, derived datasets, and statistical analyses according to agreed timelines and quality standards.
• Perform and / or supervise quality control of statistical output produced by other members of the department or external providers, including tables, listings, figures, derived datasets, and statistical analyses.
• Plan and perform statistical analysis (interim and / or final) in accordance with the Study Protocol and the Statistical Analysis Plan.
• Review and provide input in interpreting analysis results for the clinical study report.
• Contribute to clinical development plan preparation.
• Assist in performing / reviewing sample size calculations.
• Participate in international multi-stakeholder advisory boards.

Requirements :

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