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Senior Biostatistician - Vaccine

Swiftwater, Pennsylvania, Bridgewater, New Jersey

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Overview

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

JOB DESCRIPTION

The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D under the supervision of the head of Preclinical or Non-Clinical Team and/or the TED Global head who are all part of the Global Biostatistical Sciences (GBS) team. As a core objective, his/her responsibilities include but not limited to provide statistical support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC, biological assay, and biomarker research. He/She will work in close collaboration with the scientists and/or projects managers and under the supervision of the senior managers of the TED Team.

He/She will assume responsibility for methodological and statistical aspects of pre-clinical and/or non-clinical studies, with general direction from Research Project Leader or technicians. He/she will provide critical input on the design and analysis so that accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations

KEY RESPONSIBILITIES

Acts as the lead statistician and provides support, with minimal supervision from manager or TED Global Head, to the preclinical research team or non-clinical team on statistical requests and on all relevant statistical matters. His/her responsibility includes but not limited to:

  • Develop the digital mindset and data science of the clients under his/her responsibility (communications, training, etc.)

  • Support the digital evolution of the site within its scope of activity

  • Perform technology watch on data science topics and be the referent for the platform

  • Provides statistical input in the design of experiments with regards to available information and assumptions of in vivo or in vitro preclinical studies and/or research, clinical and analytical (CMC) bioassay development

  • Contribute to the setup of the study to make sure data are adequately captured and collected to address the study objectives.

  • Provide statistical support of experimental design, statistical methodology, statistical programming, and data analyses.

  • Provide statistical analyses (planning, prioritization, application forms, analysis reports), write statistical memos/reports, communicate, and explain to scientists the statistical conclusions.

  • Accountable for all statistical operations, including but not limited to: Sample size calculation and design of experiment, if applicable, Suitability and compliance of randomization plan, if applicable, Quality, compliance, and delivery of statistical methodology & statistical reports

  • Accountable for the statistical scientific content: Selects statistical methodology to support the objectives of the studies, Drives risk assessment for study conclusions if applicable, Statistical interpretation of results driving study conclusion, Proposes, prepares, and performs exploratory data analyses, ad-hoc analyses when applicable

  • Links with other internal and external stakeholders (such as R&D compliance, Functional Planner, Project Manager, CROs, etc.)

  • Under supervision of the senior manager of the TED team or Research lead, participates in project activities such as assist in preclinical development plan, decision-making meetings, integrated analyses and dossier preparation, submission (IND and CTD) and follow-up (publication).

  • Acts as representative in internal initiatives within TED and GBS

  • Presents internally and externally topics related to statistical activity

Management activity:

Cross-functional management: Collaborates with more junior statisticians or contingent workers for the preparation and production of statistical report & analyses/programming.

Accountable for management of the activities that are outsourced to external partners (CROs

REQUIRED EDUCATION / EXPERIENCE

Education

  • MS degree with minimal 4 years of industry experience or PhD degree in statistics, biostatistics, or mathematics

Experience

  • 1 to 3 years in applied mathematics, statistics, etc.

  • Experience in the biotechnology/pharmaceutical industry or other high-tech industries.

  • Technical expertise in statistics, data science, statistical modelling, etc

Soft Skills

  • Good communication skills

  • Ability to work in a multi-cultural environment

  • Ability to work in a team (team spirit, ease of communication)

  • Eager to learn and open-minded,

  • Good time management

  • Autonomous

  • Creative

  • Rigor

  • Honesty

  • Agile

Statistical Tools

  • SAS (basic + Macro), R, Other softwares (e.g. Phython is a plus

Language

  • Effective English in terms of verbal and written communication skills

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-SP

#LI-SP

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.

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