Principal Biostatistician

• Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
• Leads large projects involving complex project dynamics and ensuring alignment with strategic goals.
• Oversees data analysis initiatives; develops new methodologies and tools for data management.
• Participate in meetings with internal and external stakeholders in the discussion / defence of new study design contributing with data science expertise.
• Participate and oversee in the development of Study Protocols by providing statistical input and data specifications.
• Design and oversee eCRF design and structure to ensure that it meets the specific requirements defined in the study protocol.
• Development and / or oversee Data Science Plan for assigned projects.
• Define or review randomization procedures and produce randomization lists.
• Development and review of Statistical Analysis Plans.
• Perform and / or supervise programming of tables, listings, figures, derived datasets, and statistical analyses according to agreed timelines and quality standards.
• Perform and / or supervise quality control of statistical output produced by other members of the department or external providers, including tables, listings, figures, derived datasets, and statistical analyses.
• Plan and perform statistical analysis (interim and / or final) in accordance with the Study Protocol and the Statistical Analysis Plan.
• Review and provide input in interpreting analysis results to clinical study report.
• Contribute to clinical development of plan preparation.
• Assist in performing / review sample size calculations.
• Participation in international multi-stakeholder advisory boards.

Requirements:

• A bachelor’s degree in Life Science (Biology, Biotechnology, Biomedicine, Statistics...).
• Minimum 5 years of experience in biostatistics, with a focus on oncology clinical trials, especially in Phase III studies.
• Design of Phase I-IV clinical trials, basket, umbrella, and adaptive trials in oncology.
• Survival analysis methods (Kaplan-Meier, Cox models, hazard ratios, landmark analysis).
• Advanced statistical methodologies:
• Application of Bayesian methods and predictive modeling in oncology.
• Statistical analysis of biomarker data and precision medicine.
• Experience with patient-reported outcomes (PROs) and composite endpoints.
• Proficiency in SAS and R for advanced statistical analysis.
• Experience with CDISC standards (SDTM, ADaM) and dataset validation for regulatory submissions.
• Ability to translate complex statistical concepts for clinical, executive, and regulatory teams.
• Experience in writing and reviewing protocols, clinical study reports, and scientific publications.
• Presentation skills to defend trial designs and statistical analyses before medical, regulators and internal committees.
• Leadership in cross-functional teams (medical, regulatory, data management, and programming).
• Mentorship and supervision of junior statisticians and biostatistics teams.
• Experience with real-world evidence (RWE) and real-world data (RWD) analysis in oncology is a plus.
• Knowledge of decentralized clinical trials (DCTs) and innovative trial methodologies.
• Familiarity with medical imaging analysis and omics data in oncology.
• Ability to manage multiple projects simultaneously in a highly regulated environment with tight deadlines.