Group Head Non Clinical Biostatistics
Group Head Non Clinical Biostatistics
Cambridge, Massachusetts, Bridgewater, New Jersey
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The Biostatistics and Programming (B&P) Department mission is to provide innovative and rigorous statistical solutions to accelerate drug development and post-approval programs, with optimal chance of success, robust quality and efficient execution. Our Biostatisticians and Programmers find a share commitment to bring innovation and rigor to our diverse and competitive pipeline.
Within B&P Department, the Global Head of Research Statistics will have to provide leadership, guidance, and strategic input to an international team of non-clinical statisticians supporting non-clinical efficacy and safety area. He/She will be accountable for all statistical aspects of projects and Research programs within the group, in particular for submission dossier as IND or CTD. He/She will act as a key statistical consultant within the company. He/She will manage a team of non-clinical study/project statisticians and group leaders and will be responsible for project staffing and resource planning to optimize the allocation of resources versus workload taking into business priorities. He/She will have the mission to foster team development and ensure satisfactory performance and project delivery.
Define the strategy of statistical support in the non-clinical area in collaboration with Biostatistics and Programming senior management and the key business stakeholders. Promote usage of sound statistics and lead initiatives to ensure reliability of results for decision making based on Research experiments all along the Research and Development value chain.
Lead the statistical support for the Non-clinical Efficacy and Safety area and provide statistical expertise and guidance. Accountable for statistical aspects of projects within the group, in non-clinical studies and submissions activities, including quality, relevance to external stakeholders (e.g., regulatory authorities, medical journals), and scientific validity
Manage a team of non-clinical study, project statisticians and group leaders. Define team members priorities, performance review and development areas. Responsible for appropriate resource planning and allocation. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure 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 unscheduled increase in projects workload.
Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
Represent statistics to participate and lead key cross function initiatives
Lead key department development initiatives
PhD/MS in statistics or related discipline with more than 10/12 years of pharmaceutical experience
Excellent knowledge of pharmaceutical environment in particular in the Research area
Demonstrated very strong project management, interpersonal and communication skills
Several years of experience in direct management of an international team
Excellent knowledge and good understanding of advanced statistical concepts and techniques in particular used in non-clinical research area for efficacy and safety
Proven successful experience of contribution to the non-clinical part of a submission dossier (IND, CTD), interactions with regulatory agencies or other external stakeholders
Broad Experience in the Research area both for non-clinical efficacy and safety studies desired
Outstanding ability to influence and to contribute to the advancement of innovative statistical methodology
Ability to represent Sanofi in major cross-company activities such a consortiums or professional associations
Fluent in English
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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