Sr. Non-Clinical Biostatistician

Role Summary

Sr. Non-Clinical Biostatistician role supporting the Translational and Early Development (TED) team within Global Biostatistical Sciences. Provides statistical input for pre-clinical and non-clinical studies, bioassay and biomarker research, and related CMC activities, working with scientists, project managers, and TED leadership to ensure regulatory-compliant, data-driven decision making.

Responsibilities

• Act as the Lead Statistician and provide support with minimal supervision to the Preclinical Research Team or Non-clinical Team on statistical requests and related matters.
• Develop the digital mindset and data science capabilities of clients under responsibility, including communications and training.
• 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 for in vivo or in vitro preclinical studies, as well as clinical and analytical (CMC) bioassay development.
• Contribute to study setup to ensure data are adequately captured to address study objectives.
• Provide statistical support for experimental design, statistical methodology, programming, and data analyses.
• Prepare statistical analyses, memos, and reports; communicate statistical conclusions to scientists.
• Be accountable for statistical operations, including sample size calculation, design of experiments, randomization plan (if applicable), and quality and delivery of statistical methodology and reports.
• Ensure statistical content quality: select appropriate methodologies, drive risk assessment, interpret results to drive study conclusions, and perform exploratory or ad-hoc analyses as needed.
• Collaborate with internal and external stakeholders (R&D compliance, Project Manager, CROs, etc.).
• Under supervision, participate in project activities such as preclinical development planning, decision-making meetings, integrated analyses, dossier preparation, and submission (IND/CTD) with follow-up (publication).
• Represent TED and GBS in internal initiatives; present topics related to statistical activity internally and externally.

Qualifications

• Education: Master's degree in Statistics with 4 years of industry experience, or PhD in Statistics/Biostatistics with internship in life sciences.
• Experience: Experience in Life Sciences industries is required.

Skills

• Technical expertise in statistics, data science, statistical modelling, etc.
• Good communication skills; ability to work in a multi-cultural environment and in a team; autonomous and proactive with good time management.
• Statistical Tools: R, JMP; SAS or Python experience is a plus.
• Language: Effective English in verbal and written communication.

Education

• Master's degree in Statistics with 4 years industry experience OR PhD in Statistics/Biostatistics with internship in life science