Sr. Non-Clinical Biostatistician

Role Summary

Sr. Non-Clinical Biostatistician responsible for leading statistical support for preclinical/non-clinical studies within the TED team, providing design, analysis, and interpretation to ensure regulatory compliance and informed decision-making.

Responsibilities

• Act as the lead statistician providing statistical support with minimal supervision to the preclinical/non-clinical teams on statistical requests and matters.
• Develop the digital mindset and data science capabilities of clients; support digital evolution of the site.
• Perform technology watch on data science topics and serve as the referent for the platform.
• Provide statistical input in experimental design for in vivo/in vitro preclinical studies, CMC bioassay development, and related research.
• Contribute to study setup to ensure data are captured to address objectives.
• Provide statistical support for experimental design, methodology, programming, and data analyses; produce analyses, memos, and reports; communicate conclusions to scientists.
• Responsible for statistical operations including sample size calculations, randomization plan compliance, and delivery of statistical reports.
• Ensure statistical content is sound: select methodologies, assess risks, interpret results, and perform exploratory/ad-hoc analyses as needed.
• Coordinate with internal/external stakeholders (R&D compliance, project managers, CROs, etc.).
• Participate in project activities such as development plans, decision meetings, integrated analyses, dossier preparation, IND/CTD submissions, and publications under supervision.
• Represent TED/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 life science internship.
• Experience in Life Sciences industries is required.
• Technical expertise in statistics, data science, and statistical modeling.

Skills

• Good communication; ability to work in a multi-cultural environment and in a team; autonomous and good time management.
• Experience with statistical tools: R, JMP; familiarity with SAS or Python is a plus.
• Effective English written and verbal communication.

Education

• Master's degree in Statistics (with 4 years of industry experience) or PhD in Statistics/Biostatistics.

Additional Requirements

• Experience in Life Sciences industries is mandatory.