Sr. Non-Clinical Biostatistician

Role Summary

Senior non-clinical biostatistician supporting the Translational and Early Development (TED) team within Global Biostatistical Sciences. Provides statistical support for preclinical and non-clinical studies, bioassay and biomarker research, and related CMC activities. Leads statistical design, analysis, and interpretation under minimal supervision, collaborating with scientists, project managers, and external partners to ensure regulatory-compliant conclusions.

Responsibilities

• Act as the Lead Statistician and provide support to the Preclinical Research Team or Non-clinical Team on statistical requests and all relevant statistical matters with minimal supervision.
• Develop the digital mindset and data science capabilities of 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 serve as the referent for the platform.
• Provide statistical input in the design of experiments regarding in vivo or in vitro preclinical studies and/or research, clinical and analytical (CMC) bioassay development.
• Contribute to the setup of studies to ensure data are adequately captured to address objectives.
• Provide statistical support for experimental design, statistical methodology, programming, and data analyses.
• Prepare statistical analyses (planning, prioritization, forms, analyses), write memos/reports, and communicate statistical conclusions to scientists.
• Ensure accountability for statistical operations, including sample size calculation, design of experiments, randomization plan, and quality and delivery of statistical methodology and reports.
• Ensure accountability for statistical content: select methodologies, assess risk, interpret results, perform exploratory/ad-hoc analyses as needed.
• Coordinate with internal and external stakeholders (R&D compliance, Project Manager, CROs, etc.).
• Under supervision, participate in preclinical development planning, decision meetings, integrated analyses, dossier preparation, IND/CTD submission, and publications follow-up.
• Represent TED and GBS in internal initiatives and present statistical topics internally and externally.

Qualifications

• 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 required.
• Technical expertise in statistics, data science, and statistical modeling.

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 science, statistical modeling, etc.

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

• R, JMP; other software (e.g., SAS or Python) is a plus.

Language

• Effective English in verbal and written communication.