Statistical Project Leader, Global Biostatistics Sciences - Vaccines

Job description

Job Summary

Serves as a statistical project lead on a small to medium size project(s) or new project indications. The Statistical Project Leader, Global Biostatistics Sciences represents the Biostatistics group at extended clinical team meetings, and may attend external meetings with regulatory agencies and key opinion leaders.

Key accountabilities:

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Acts as the lead statistician at project level for projects of small/medium size or new project indication, and provides support and leadership to project needs on all relevant statistical matters

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Collaborates with statistical programmers and the programming project leader for the preparation and production of statistical reports & appendices at the trial and project level

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Manages and follows-up the activities that are outsourced to external partners (CROs)

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Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, SMTs)

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May represent Sanofi BIOS group externally in interactions and meetings with Regulatory Authorities, expert panels, statistical experts, independent data monitoring committees

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May act as the lead statistician at clinical trial level and provides support and leadership to the clinical trial team on all relevant statistical matters

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Acts as a mentor within BIOS platform for junior statisticians

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Acts as BIOS representative in internal initiatives within GCD

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Participates in research groups, presentations and publications of statistical topics

Required Education/Experience:

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PhD/MS in statistics or related discipline with at least 3-6 years of pharmaceutical experience

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Demonstrated strong study management, interpersonal and communication skills

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Broad knowledge and good understanding of advanced statistical concepts and techniques

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Experience in the relevant therapeutic area desired

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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