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Job Summary
As a Statistical Project Leader, you will provide statistical leadership and guidance for clinical studies in one or more indications and will be accountable for methodological and statistical aspects of clinical development or medical affairs plans and subsequent deliverables. Utilizing strong study management, interpersonal and communication skills, you will be expected to ensure productive collaborations with other functions, as well as with other statistical project leaders and in communicating with senior leadership. You will promote teamwork, quality, operational efficiency, and innovation, as also represent Biostatistics (or provide leadership) in scientific or technology working groups or cross functional initiatives.
Major Duties and Responsibilities
With minimal direction from the group head, direct statistical support and provide scientific leadership for one moderate project, one or several indications or a highly complex large study in Neurology late phase.
Be accountable for statistical aspects of late clinical development, studies and submissions activities (when applicable), including relevance to external stakeholders (e.g. regulatory authorities, medical journals) and scientific validity, according to internal standards and regulatory guidelines, and in compliance with SOPs.
Plan and track project activities, timelines, and resource use. Seek to optimize resource utilization through efficient and well-managed resource allocation and across projects or areas.
Provide justifications for planned resource needs, allowing for the capacity to respond to unscheduled increase in project workload as needed. Effectively utilize external groups, e.g. CROs or data monitoring committees (DMCs), as applicable.
Represent Statistics in regulatory meetings.
Act as statistical consultant within company, and provide technical guidance and mentoring to people working on the projects.
Contribute to process optimization and provide input to statistical standards.
Required Education/Experience
PhD/MS in statistics or related discipline with at least 6 years of pharmaceutical experience.
Broad experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies or other external stakeholders.
Broad knowledge and good understanding of advanced statistical concepts and techniques.
Experience in Neurology therapeutic areas preferred.
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.
The salary median compensation for this position is $180,687. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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