Statistical Project Lead - Biomarker
Sanofi

Job Info

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Job Title: Statistical Project Lead - Biomarker

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.

The Statistical Biomarker Leader is involved in the clinical development process from early on to lead the statistical aspects of the biomarker discussions as part of the clinical project team and is responsible for generation actionable data-driven insights from clinical biomarkers to optimize targeted patient population and increase the productivity of drug development in one or more therapeutic areas (e.g., oncology, immunology & inflammation, neurology, rare disease, and rare blood disorders).

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:

• Lead in multiple complex projects / one or several indications of a project in clinical development phases with regard to statistical activities in Precision Medicine and Biomarker activities.
  
• Leverage biomarker data/evidence from different sources (e.g., pre-clinical data, RWE, publications) and provide appropriate input for the development of the biomarker strategy of a clinical project in collaboration with project team members.
  
• Implement innovative data analytical tools (e.g., AI, machine learning) and statistical methodologies to transform the complex biomarker data into insights that can be readily used in drug development.
  
• Planning, analyzing, and reporting of various of biomarker data (e.g., biomarker profiles, genome-wide datasets, medical imaging data, continuous data from wearable devices) collected from clinical studies for both formal reporting and exploratory analyses purposes.
  
• Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
  
• Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment.
  
• 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 project workload. Ensure project team compliance with SOPs and departmental standards.
  
• Represents statistics in regulatory discussions and meetings for biomarker topics
  
• Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross-functional initiatives
  
• Provide technical guidance and mentoring to junior staff.
  

About You

• PhD/MS in statistics or related discipline with a minimum of 6 years of pharmaceutical experience
  
• Demonstrated strong study management, interpersonal and communication skills
  
• Broad knowledge and good understanding of advanced statistical concepts and techniques in various biomarker data collected in clinical studies
  
• General knowledge of pharmaceutical clinical development and the process of clinical decision making; experience of using biomarker data in clinical decision-making process is desired
  
• Broad Biomarker knowledge
  
• Proven experience in clinical development, interactions with regulatory agencies or other external stakeholders is desired
  
• Ability to represent Sanofi in cross-company activities such a consortia 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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