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Senior, Statistical Project Leader

Company: Sanofi
Location: Cambridge
Posted on: November 24, 2022

Job Description:

Position Overview:At Sanofi, we have a shared commitment to provide innovative scientific and methodological solutions to accelerate clinical development and enhance probabilities of success. The Rare Diseases and Rare Blood Disorders Biostatistics and Programming group is a valued partner in development strategy and execution, from clinical studies design up to submission and approval.Provide leadership, guidance, and strategic input as the lead statistician on one or more project team(s), accountable for all statistical aspects of project(s). Act as key statistical consultant within company. Work with Group head about project staffing and responsible for resource planning and allocation within project B&P team.Major Duties and Responsibilities:

  • Lead one large project or multiple complex projects in late phase or MA; lead multiple complex projects in early development and being a recognized cutting edge statistical domain leader
  • Direct statistical support and provide statistical leadership for responsible project(s). Accountable for statistical aspects of early or late 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
  • In charge of all statistical inputs for submission documents, such as IND, NDA, BLA, CTE or CTD to insure statistical validity and accuracy
  • Manage transversally B&P staff working on the project. Work with group head to define team members priorities, performance review and development areas. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project 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 project workload.
  • Provide technical guidance and mentoring to junior staff.
  • Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
  • Represents statistics in challenging regulatory meetings (ex: Advisory Committee)
  • Represent statistics to participate (and lead if applicable) in key scientific or technology working groups or lead key cross function initiatives. Contribute to operation process optimization with senior leadershipRequired Education/Experience:
    • PhD/MS in statistics or related discipline with more than 8 years of pharmaceutical experience
    • Excellent knowledge of pharmaceutical clinical development, together with Late Phase experience.
    • Demonstrated very strong project management, interpersonal and communication skills
    • Excellent knowledge and good understanding of advanced statistical concepts and techniques
    • Proven successful experience in clinical development or post-marketing activities such as a submissions, interactions with regulatory agencies or other external stakeholders
    • Broad Experience in the relevant therapeutic area desired
    • Ability to represent Sanofi in major cross-company activities such a consortiums or professional associationsAt Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.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.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.#GD-SA
      #LI-SAAt 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 all.

Keywords: Sanofi, Cambridge , Senior, Statistical Project Leader, Other , Cambridge, Massachusetts

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