Sanofi Group Biostatistics Project Leader in Cambridge, Massachusetts
Stat Project Leader, Biostatistics
Provide leadership and guidance as to the lead statistician on one or more project team(s), accountable for all methodological and statistical aspects of the project(s). Act as a statistical consultant within the company.
Major Duties and Responsibilities:
Lead moderate project / one or several indications of a project in early or late clinical development or post-marketing stage.
With minimal direction from the group head, direct statistical support and provide scientific leadership for responsible projects. 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 a 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.
Capacity to respond to an 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 in cross-function working groups. Contribute to operation process optimization and provide inputs to statistics standards.
Ph.D./MS in statistics or related discipline with at least 6 years of pharmaceutical experience.
Demonstrated strong study management, interpersonal and communication skills.
Broad knowledge and a good understanding of advanced statistical concepts and techniques * Broad knowledge of pharmaceutical clinical development, together with Late Phase experience.
Proven experience in clinical development or post-marketing activities such as 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 as consortiums or professional associations.
Sanofi Genzyme will be positioned to become a world leader in rare blood disorders. The Rare Blood Disorders franchise focus on growth with an unmatched hemophilia portfolio, the first approved treatment for acquired thrombotic thrombocytopenic purpura (aTTP), and the potential to launch several more therapies over the next five years, providing the opportunity to bring new therapies to patients who currently have few options. With fast growing pipeline, this position will play a very important role to provide statistical leadership in the clinical development.
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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