Responsibilities:
* 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.