Biostatistics Associate Director - Oncology, Cambridge, MA
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Associate Director, Oncology Biostatistics
Building on its strong heritage, Sanofi takes the opportunity to present new, early-stage studies highlighting an emerging and dynamic portfolio that encompasses diverse strategies in oncology. With fast growing pipeline in oncology early development, this position will play a very important role to provide statistical leadership in the clinical development.
Provide leadership and guidance as the lead statistician on a project team in Oncology. For one or more projects, be accountable for all 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 therapeutic area(s). In some cases incumbent could serve as department leader in specific technical area.
- Project - With minimal direction from departmental management, direct statistical support and provide scientific leadership for responsible project. Accountable for statistical aspects of clinical studies and submissions of the project: provide innovative and high quality statistical support for creation of clinical development plans (CDP), study design, analyses and operational aspects. Design and execution of CDPs consistently meeting internal guidelines and regulatory requirements. Maintain awareness of industry standards and regulatory requirements and novel methodologies/technologies.
- Mentor people working on the project. Promote teamwork, quality, and innovation. Ensure project team compliance with SOPs and departmental standards.
- Resource Management - 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.
- Collaboration - Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
- Represent statistical group 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 6+ (8+) years of pharmaceutical experience, including experience in oncology clinical development
- Proven success, through previous submissions or significant interactions, in meeting regulatory guidelines and requirements for drug development
- Broad knowledge and superior understanding of advanced statistical concepts and techniques. Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
- Demonstrated project management, interpersonal skill
- Excellent verbal, writing, and presentation skills
Cambridge preferred. Bridgewater possible.
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