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The Statistical Project Leader serves as the lead on small to mid-size project(s) or new project indications. The Statistical Project Leader represents the Biostatistics group, and will participate at extended clinical team meetings and may attend external meetings with regulatory agencies and key opinion leaders. Main Responsibilities include acting as the lead statistician at project level for projects of small/medium size or new project indication, providing support and leadership to project needs on all relevant statistical matters, collaborating with statistical programmers and the programming project leader for the preparation and production of statistical reports & appendices at the trial and project level, managing and following-up the activities that are outsourced to external partners (CROs), linking with other internal stakeholders such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, SMTs, representing Sanofi BIOS group externally in interactions and meetings with Regulatory Authorities, expert panels, statistical experts, independent data monitoring committees, acting as the lead statistician at clinical trial level and providing support and leadership to the clinical trial team on all relevant statistical matters, mentoring junior statisticians within BIOS platform, acting as BIOS representative in internal initiatives within GCD, and participating in research groups, presentations and publications of statistical topics. Requirements include a PhD in statistics or related discipline with 2+ years of applicable pharmaceutical or biotech experience, or a Master's degree with 5+ years of experience, broad knowledge and good understanding of advanced statistical concepts and techniques with hands-on experience doing statistical simulations, experience using R is strongly preferred, and strong interpersonal and communication skills with the ability to work collaboratively on multiple projects with multiple stakeholders.
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