Director, Biostatistics Project Lead

Sanofi; Waltham (MA); On-site; USD 179,000 - 258,000; Full time

Job summary

Sanofi in Waltham, MA seeks a Director, Biostatistics Project Lead to provide leadership as the lead biostatistician on project teams and cross-functional groups, accountable for all statistical aspects of the programs.

You will mentor global Biostatistical teams, drive statistical strategy, and ensure regulatory-aligned analyses and submissions. A PhD/MS in statistics with 8+ years pharma experience, strong project management and communication skills are required.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Project management

Interpersonal skills

Communication skills

Education

PhD/MS in statistics or related discipline

Job description

Job Title: Director, Biostatistics Project Lead

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.

Main responsibilities

• 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.

About you

Required Education/Experience

• 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. #GD-SP #LI-SP #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and ... (continues ...) North America Applicants Only The salary range for this position is: $178,500.00 - $257,833.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies.