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Principal Biostatistician

Principal Biostatistician

DNA Life Sciences, Cataluña, Spain, Cataluña, España
Hace 17 días
Descripción del trabajo
  • 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 / defense 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.

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