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Job Title: Non-clinical Statistics Project Lead

Location: Swiftwater, PA OR Morristown, NJ

About the Job

The Non-clinical Statistics Project Lead of the TED (Translational and Early Development) team supports Vaccine R&D under the supervision of the head of Non-Clinical Statistics Team and/or the TED Global head who are all part of the Global Biostatistical Sciences (GBS) team. As a core objective, the Project Lead responsibilities include provideing statistical support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC, biological assay, and biomarker research, as well as working in close collaboration with the scientists and/or project managers.

The Project Lead will assume responsibility for methodological and statistical aspects of non-clinical studies, with general direction from their manager, and will provide critical input on the design and analysis so that accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Act as the lead statistician and provide support, with minimal supervision from manager or Global Head, to the clinical research team or non-clinical team on statistical requests and on all relevant statistical matters. Responsibilities include:

• Take the lead on clinical bioassay development, validation and monitoring projects

• Develop the digital mindset and data science of the clients under your (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 with regard to available information and assumptions of in vivo or in vitro preclinical studies and/or research, clinical and analytical 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

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

• Participate 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).

• Act as representative in internal initiatives within TED and GBS

• Present 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)

About You

• Earned Master's degree or PhD in statistics, biostatistics, data science, or a relevant field.

• 7+ years (MSc) or 5+ years (PhD) of experience in statistics, biostatistics or related mathematical/statistical field required

• Experience in the biotechnology/pharmaceutical industry required.

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

• Experience with statistics for bioassay development, validation, and monitoring needed.

• Experience working with clinical bioassays (using patient samples) is highly preferred.

• Expertise in R and/or JMP required, other statistical software (e.g. SAS or Python, etc) is preferred

• Experience working within a GxP environment (GCP, GCLP, GLP, etc) is preferred

• Strong written and verbal communication skills, as well as the ability to negotiate and present information to internal and external stakeholders

• Desire and ability to work as part of a collaborative team

• Eager to learn, with the ability to adapt to shifting priorities

• Strong time management skills and the ability to produce quality results on time

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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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.

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