Provide leadership and guidance as the lead statistician on one or more project team(s) in Neuroscience, accountable for statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical consultant within company. Responsible for project staffing, resource planning and allocation within project team(s).
Major Duties and Responsibilities
- Lead large or complex late phase project(s) / multiple indications of a large late phase project(s). Represent stat leadership in cross function working groups. Provide insights to innovative statistical application and operation strategies
- Mentor people working on the project. Promote teamwork, quality, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards.
- Direct statistical support and provide scientific leadership for one or more projects of clinical development. Accountable for statistical aspects of clinical studies and submissions of the project(s).
- 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. Capacity to respond to unscheduled increase in project workload.
- Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
- PhD/MS in statistics or related discipline with at least 8-10 years of pharmaceutical experience
- Demonstrated leadership, project management, and interpersonal/communication skill
- Broad knowledge and superior understanding of advanced statistical concepts and techniques
- Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
- Experience in neuroscience clinical trials preferred but not required
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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