Senior Nonclinical Statistician

About the role

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.

Responsibilities

• 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.
• Provide 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.
• 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).

Qualifications

• Master's degree in a relevant field with 4 years of Life Science industry experience OR
• PhD in a relevant field with 1 year of Life Science industry experience.
• Technical expertise in statistics, data science and statistical modelling.
• Proficiency in R programming language.

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.

Statistical Tools

• JMP or other softwares (e.g. SAS or Python) is a plus.

Language

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

Benefits

Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pay

All compensation will be determined commensurate with demonstrated experience.

Schedule

N/A

Skills

None specified

Location

Swiftwater, Pennsylvania