Global Statistical Head of Safety CoE at Sanofi in Cambridge, Massachusetts

Job Description:

Job Title: Global Stat Head of Safety CoE



Location: Cambridge, MA



About the Job



Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Safety Analytics Team and you'll provide leadership, guidance, and strategic input as Global Stat Head of Safety Analytics CoE.


Assume global responsibility for this group. Be accountable for all statistical aspects of clinical trial safety data within the group (safety surveillance, signal detection & characterization, safety reporting including for regulatory purpose). Lead cross-functional safety initiatives, drive and promote innovations. Act as key statistical consultant on safety related topic within company and contribute/lead cross-company initiatives. Manage a global team of statisticians, including Senior Safety Expert Statisticians leading multiple projects across therapeutic areas. Responsible for staffing and resource planning. Foster team development and ensure satisfactory performance and delivery. Lead key department development initiatives.


We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?



Main Responsibilities

• Direct/oversee statistical support and provide statistical leadership for safety oriented analyses. Accountable for statistical aspects and deliverables of safety oriented analysis at project level (safety surveillance, safety surveillance, signal detection & characterization, safety reporting including for regulatory purpose).
  
  


• Manage a global team of statisticians in charge of all safety analysis at project level. 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.
  
  


• Ensure productive collaborations with other functions in the aligned project safety monitoring team (SMT), with statistics project leaders and safety statistical analysts (Hub), and in communicating with senior leadership.
  
  


• Represents statistics in regulatory meetings dedicated to safety
  
  


• Act as key safety statistical consultant within company.
  
  


• Represent statistics to participate and lead key cross function initiatives and drive innovations. Develop, promote state-of-the-art methodology and standards for safety analyses.
  
  


• Lead key department development initiatives
  
  

About You




Skills

• Strong interpersonal and communication skills and ability to work collaboratively in a global and cross-functional team environment on multiple priorities and projects simultaneously.
  
  


• Very strong project management skills, organizational skills, and ability to prioritize competing tasks
  
  


• Dynamic leader with outstanding ability to influence
  
  

Required Education/Experience:

• PhD/MS in statistics or related discipline with more than 10 years of pharmaceutical experience,
  
  


• Knowledge of epidemiology methods and concepts in safety context. In-depth understanding of and expertise in safety analytics methodology
  
  


• Excellent knowledge of pharmaceutical clinical development.
  
  


• Demonstrated very strong project management, and excellent interpersonal / communication skills
  
  


• People management experience
  
  


• Excellent knowledge of advanced statistical concepts and techniques and contribution to the advancement of innovative statistical methodology
  
  


• Proven successful experience in clinical development or post-marketing activities such as a submissions, interactions with regulatory agencies or other external stakeholders
  
  


• Demonstrated and recognized expertise in operational or statistical or managerial aspects
  
  


• Broad Experience in several therapeutic area desired
  
  


• Ability to represent Sanofi in major 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.
  
  

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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