Director, Biostatistics Project Lead

** Job Title** :
Director, Biostatistics Project Lead

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Location:

Waltham, MA

** About the job*
* Provide leadership and guidance as the lead biostatistician on one or more project team(s) and cross-functional teams, accountable for all statistical aspects of project(s).  Act as statistical consultant within company.

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.

** About Sanofi*
* We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

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* Main responsibilities:

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* + Lead large business critical vaccine project (one or several indications) in either clinical development or post-marketing stage.

+ With minimal Biostat Franchise Lead oversight, take accountability in directing the biostatistical contribution and in providing scientific leadership for related project. The accountability covers for statistical aspects of 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 and Lead global Biostatistical and Scientific Programming team members involved and located in France/US/China or India.  Promote global teamwork, quality, operational efficiency, and innovation. Create productive work environment.  Ensure project team compliance with SOPs and departmental standards.

+ Plan and track Global Biostatistical Sciences activities, timelines and resource use globally.  Provide justification for planned resource needs.  Seek to optimize resource utilization through efficient and well-managed resource allocation.  Capacity to respond to unscheduled increase in project workload.

+ Ensure productive collaborations with other functions within the project team and in communicating with senior leadership.

+ Represent biostatistics in cross function working groups within or outside Sanofi. Contribute to operation process optimization and provide inputs to statistics standards.

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* About you:

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* ** Required Education/

Experience:

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* + PhD/MS in statistics or related discipline with at least 8 years of pharmaceutical experience.

+ Demonstrated strong project management, interpersonal and communication skills.

+ Broad knowledge and good understanding of advanced statistical concepts and techniques.

+ Proven experience in clinical development or post-marketing activities such a 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 a consortiums or professional associations.

** Why Choose Us?*
* + Bring the miracles of science to life alongside a supportive, future-focused team.

+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.

+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

+ Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

+ Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

+ Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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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