Sr. Non-Clinical Biostatistician

Job Title: Sr. Non-Clinical Biostatistician

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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.

Main responsibilites

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).

Education/Experience

Education

• Master's degree in Statistics with 4 years industry experience OR

• PhD in Statistics/Biostatistics with internship in life science

Experience

• Experience in Life Sciences industries is a must.

• Technical expertise in statistics, data