Non-Clinical Biostatistician

We are seeking a Non-Clinical Biostatistician to provide statistical expertise across the full research and development process in the pharmaceutical/biotech sector. You will define, execute, and report statistical analyses for non-clinical studies, including discovery experiments, toxicology programs, PK/PD, and CMC studies. The ideal candidate is proactive, innovative, and motivated to tackle complex scientific questions while supporting decision-making in drug development.

Key Responsibilities

• Act as the lead statistician for non-clinical projects, including discovery, toxicology, and CMC studies.
• Design experiments, calculate sample sizes, and contribute to study protocols and reports.
• Develop, validate, and maintain statistical programs for data parsing, visualization, and analyses.
• Review analyses from external partners (CROs) and interpret results alongside scientific teams.
• Apply and improve statistical methodologies for complex non-clinical questions.
• Provide statistical guidance and training to scientists and stakeholders.
• Support publications, press releases, and presentations with statistical expertise.
• Ensure regulatory compliance (ICH-GxP) and implement reproducible research practices (R Markdown/Quarto, version control, cloud-based environments).

Required Skills & Experience

• Master’s degree in Statistics, Biostatistics, or a related field; PhD is a plus.
• 5-10 years of non-clinical biostatistics experience in pharmaceutical or biotech settings.
• Strong expertise in SAS, R, Python, and statistical analysis of animal models, PK/PD, and toxicology studies.
• Solid understanding of experimental design, sample size calculations, and dose-response modeling.
• Excellent English communication skills, both written and verbal.
• Ability to work independently and collaboratively across multidisciplinary teams.
• Experience with reproducible research, version control (GitHub), and cloud-based data environments (AWS, MS OneLake, Databricks).
• Knowledge or interest in (auto-)immune disease research is highly desirable.

Why This Role?

• Contribute directly to the development of innovative therapies for patients with unmet needs.
• Work in a collaborative, dynamic environment with a strong focus on scientific excellence.
• Opportunity for long-term engagement and professional growth.