Group Head Non Clinical Biostatistics
Posted on: November 18, 2023
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
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
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
Several years of experience in direct management of an
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.
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
Keywords: Sanofi, Cambridge , Group Head Non Clinical Biostatistics, Healthcare , Cambridge, Massachusetts
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