Biostatistics Project Leader (Associate Director)
Cambridge, Massachusetts, Bridgewater, New Jersey
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Provide leadership and guidance as the lead statistician on one or more project team(s), accountable for all methodological and statistical aspects of project(s). Act as statistical consultant within company.
Major Duties and Responsibilities
- Lead one moderate project, one or several indications or a highly complex large study in late phase or Onco early development; lead multiple projects including at least one complex project in non-Onco early development and MA;
- With minimal direction from group head, direct statistical support and provide scientific leadership for responsible project. Accountable for statistical aspects of early or late clinical development/medical affairs 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.
- Represents 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.
- PhD/MS 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 relevant 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.
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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