Sanofi Group Statistical Project Leader (Associate Director) Biostatistics in Cambridge, Massachusetts
Provide leadership and guidance as the lead statistician on one or more project team(s) in early phase oncology (First-in-Human to End-of-Phase 2), accountable for all methodological and statistical aspects of project(s). Act as statistical consultant within company.
Major Duties and Responsibilities:
Lead all statistical aspects in one or more early phase oncology project(s) development.
With minimal direction from group head, direct statistical support and provide scientific leadership for responsible project(s).
Accountable for statistical aspects of clinical development plans, studies and regulatory interaction activities (when applicable) including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.
Provide innovative and high quality statistical support for creation of clinical development plans (CDP), study design, analyses and operational aspects.
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.
Required Education/Experience :
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 such as clinical plan development, strategic discussion of regulatory path, 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.
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