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Study Statistician

Company: Sanofi
Location: Bridgewater
Posted on: November 25, 2022

Job Description:

At Sanofi, we have a shared commitment to bring innovation and rigor to our competitive program, from bench to bedside. Our global department invests in the development of all our team members, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients' lives.

Position Overview

Assume responsibility for methodological and statistical aspects of one or several clinical studies, under close supervision of statistical project leader and/or team leader. Support one or several late phase studies or lead one or several standard studies or domains in non-onco early development. Act as a statistical consultant within the study team.

Major Duties and Responsibilities

  • Provide support to the clinical trial study team on all assigned statistical matters in collaboration with programmers:
  • Provide high quality input into the design of the clinical study ( including protocol development), the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses,
  • Accountable for all assigned statistical deliverables related to one study or specific domain: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology etc., Statistical Analysis plan, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables) ,
  • Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan,
  • Perform and/or coordinate with study programmer the production of statistical analyses. Review and examine statistical data distributions/properties,
  • Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
  • Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.
  • Contribute to define and review the specific deliverables related to Transparency and Disclosure
  • Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation.
  • Represent statistics to participate in scientific or technology working groups or cross function initiatives Required Education/Experience:
    • PhD in statistics or related discipline.
    • Basic knowledge of pharmaceutical clinical development
    • Good knowledge and good understanding of key statistical concepts and techniques
    • Able to work in departmental computing environment, do advanced statistical analyses using SAS and possibly other languages (R, )
    • Demonstrated interpersonal and communication skills At 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.

      At 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, Trenton , Study Statistician, Other , Bridgewater, New Jersey

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