Sr. Non-Clinical Biostatistician

Overview

Job Title: Sr. Non-Clinical Biostatistician

Location: Swiftwater, PA

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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 part of the Global Biostatistical Sciences (GBS) team. The core objective is to provide statistical support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC, biological assay, and biomarker research.

Collaboration with scientists and project managers is required, under supervision of senior TED team managers.

Responsibilities include methodological and statistical input for pre-clinical and/or non-clinical studies, ensuring regulatory compliance and providing design and analysis input for decision-making.

• Act as the Lead Statistician and provide support with minimal supervision to the Preclinical Research Team or Non-clinical Team on statistical requests and all relevant statistical matters.
• Develop the digital mindset and data science of the clients under 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.
• Provide statistical input in the design of experiments for preclinical studies and/or research, bioassay development (in vivo/in vitro, clinical, analytical CMC).
• Contribute to the setup of the study to ensure data are adequately captured to address objectives.
• Provide statistical support of experimental design, statistical methodology, programming, and data analyses.
• Prepare statistical plans, memos/reports, and communicate statistical conclusions to scientists.
• Accountable for statistical operations: sample size calculation, design of experiments, randomization plan (if applicable), and delivery of statistical reports.
• Accountable for statistical content: select methodologies, drive risk assessment, interpret results, perform exploratory/ad-hoc analyses.
• Coordinate with internal and external stakeholders (R&D compliance, Project Manager, CROs, etc.).
• Under supervision, participate in project activities including preclinical development plans, decision meetings, integrated analyses, dossier preparation, IND/CTD submission, and publication follow-up.
• Represent TED and GBS in internal initiatives and present topics related to statistical activity.

Management Activity

• Cross-functional collaboration with junior statisticians or contingent workers for statistical reports and analyses/programming.
• Manage activities outsourced to external partners (CROs).

• Master's degree in Statistics with 4 years of industry experience OR
• PhD in Statistics/Biostatistics with internship in life science

• Experience in Life Sciences industries is a must.
• Technical expertise in statistics, data science, statistical modelling, etc.

• 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.

• R, JMP, Other softwares (e.g. SAS or Phython) is a plus.

• Effective English in terms of verbal and written communication skills.

• 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 or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.