Principal Biostatistician - Translational Medicine

About the role

Cytel is recruiting a Principal Biostatistician for a global pharmaceutical client working on translational medicine and translational clinical oncology. The role is sponsor-dedicated and fully embedded within the client, with Cytel providing support. The Principal Biostatistician provides statistical and development support for the client's trials, influences clinical development plans, concept sheets and protocols, and may oversee work supported by other vendors.

Key responsibilities

• Provide statistical expertise for translational medicine and translational clinical oncology projects across all stages of drug development.
• Develop statistical analysis plans (SAPs), analysis specifications and statistical methodologies for translational research and clinical oncology studies.
• Design and analyse biomarker-driven studies, including exploratory, predictive, prognostic, pharmacodynamic and pharmacogenomic analyses.
• Support early-phase oncology trials (Phase I and II, dose-escalation, dose-expansion, proof-of-concept).
• Analyse clinical, molecular, genomic, proteomic and other translational datasets, and investigate relationships between biomarkers, treatment response, safety, efficacy and outcomes.
• Collaborate with clinical and translational scientists to define endpoints, analysis populations and statistical approaches.
• Contribute to SAPs, protocols, data review plans and clinical study documentation.
• Interpret results and communicate them through technical reports, presentations, data visualisations and publications.
• Ensure deliverables meet quality standards, study requirements and regulatory and industry guidelines.
• Work with biostatistics, clinical data management, bioinformatics, biomarker and programming teams.

Required profile

• Master's or Ph.D. in Statistics, Biostatistics, Applied Mathematics, Data Science or a related quantitative discipline.
• Experience in biostatistics or statistical analysis in pharmaceutical research, biotechnology, clinical research or drug development.
• Experience supporting translational medicine, translational research or clinical oncology programmes.
• Strong understanding of statistical principles applied to clinical trials and biomarker research.
• Ability to interpret complex datasets and turn analytical results into scientific insights.
• Strong communication, documentation, problem-solving and cross-functional collaboration skills.

Required skills

• Statistical programming in R, SAS or Python.
• Knowledge of clinical trial design, oncology endpoints, biomarker analysis and exploratory statistical methods.
• Experience developing SAPs and analysing clinical or translational data.