Requirements: English
Company: DNA Life Sciences
Region: Len , Castile and Len
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 bachelors 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.