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Sanofi Group Statistical Project Leader, Associate Director in Bridgewater, New Jersey

Position Overview:

Provide leadership and guidance as the lead statistician on one or more project team(s) in late phase I&I disease areas, accountable for all methodological and statistical aspects of project(s). Act as statistical consultant within company.

Major Duties and Responsibilities:

  • Lead one indication in late phase I&I disease areas development.

  • With minimal direction from group head, direct statistical support and provide scientific leadership for the responsible project.

  • Accountable for statistical aspects of clinical development plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.

  • Mentor people working on the project.

  • Promote teamwork, quality, operational efficiency, and innovation.

  • Create productive work environment.

  • Ensure project team compliance with SOPs and departmental standards.

  • Plan and track project activities, timelines, and resource use.

  • Provide justification for planned resource needs.

  • Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas.

  • Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC).

  • Capacity to respond to unscheduled increase in project workload.

  • Provide technical guidance and mentoring to junior staff.

  • Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.

  • Represent statistics in regulatory meetings.

  • Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives.

  • Contribute to operation process optimization and provide inputs to statistics standards.

Required Education/Experience:

  • PhD in statistics or related discipline with at least 6 years of pharmaceutical experience.

  • Demonstrated strong project/study management, interpersonal and communication skill.

  • Broad knowledge and good understanding of advanced statistical concepts and techniques.

  • Broad knowledge of pharmaceutical clinical development.

  • Broad experience in clinical development or post-marketing activities such a submissions, interactions with regulatory agencies or other external stakeholders.

  • Experience in the I&I therapeutic area desired.

  • Ability to represent Sanofi in cross-company activities such a consortiums or professional associations.

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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