Responsibilities:
* 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.