Associate Director Biostatistics

• Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
• Possesses in-depth knowledge of the latest clinical research trends and developments. Demonstrates a strong understanding of the global landscape and its implications for clinical research.
• Leads large projects involving complex project dynamics and ensuring alignment with strategic goals.
• Improves quality assurance activities. Consistently demonstrates a high level of attention to details and documentation management.
• Leads risk management activities / projects; monitors and reports on risk status and effectiveness of controls.
• 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.
• Define criteria for different populations for the analysis (e.g., Safety, ITT, PP) and perform the programming for the implementation of the criteria.
• Plan and perform statistical analysis (interim and / or final) in accordance with the Study Protocol and the Statistical Analysis Plan.
• Validation of the defined statistical methods (by e g goodness-of-fit tests or model checking).
• Document and validate programs and files for analysis.
• Manage clinical data to ensure security and confidentiality.
• Produce statistical reports.
• Assist in writing / reviewing the statistical sections in the study report.
• Collaborate with other team members : clinicians, clinical researchers, operations, data management and software programmer.
• 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.
• Contributes to the departmental strategy and goals, to ensure alignment with overall company strategy and goals

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.
• Familiarity with clinical data management tools (EDC, IRT).
• Knowledge of Python for exploratory analysis and machine learning applications in oncology.
• Strong knowledge of ICH-GCP, FDA, and EMA regulations and oncology-specific statistical guidelines.
• Experience in preparing and defending statistical packages for regulatory submissions.
• Participation in regulatory meetings (eg : Advisory Boards).
• Preparation of responses to regulatory queries and support in FDA / EMA interactions.
• Implementation of statistical methodologies to evaluate efficacy, safety, and benefit-risk per regulatory requirements.