Non-clinical Statistics Project Lead

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, e