Associate Director Biostatistics

DNA Life Sciences; Lérida; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in life sciences is seeking a Senior Biostatistician to lead projects in oncology clinical trials. The role involves overseeing statistical analysis, ensuring quality assurance, and collaborating with various stakeholders to align departmental strategies with company goals. Candidates should possess a Bachelor's degree in Life Sciences and extensive experience in biostatistics, particularly in Phase III studies.

Formación

• 5+ years of biostatistics experience in oncology clinical trials.
• Experience designing Phase I-IV trials.
• Strong knowledge of regulatory guidelines.

Responsabilidades

• Lead large projects ensuring alignment with strategic goals.
• Oversee data analysis initiatives and develop methodologies.
• Collaborate with clinicians and researchers.

Conocimientos

Biostatistics

Survival analysis

Statistical methodologies

Data management

Educación

Bachelor’s degree in Life Sciences

Herramientas

SAS

R

Python

Descripción del empleo

Job Responsibilities

1. Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
2. Possess in-depth knowledge of the latest clinical research trends and developments, demonstrating a strong understanding of the global landscape and its implications for clinical research.
3. Lead large projects involving complex dynamics, ensuring alignment with strategic goals.
4. Improve quality assurance activities with a high level of attention to detail and documentation management.
5. Lead risk management activities, monitor and report on risk status and control effectiveness.
6. Oversee data analysis initiatives; develop new methodologies and tools for data management.
7. Participate in meetings with stakeholders, defending study designs with data science expertise.
8. Oversee the development of Study Protocols, providing statistical input and data specifications.
9. Design and oversee eCRF structures to meet study protocol requirements.
10. Develop and oversee Data Science Plans for projects.
11. Define or review randomization procedures and produce randomization lists.
12. Review and develop Statistical Analysis Plans.
13. Supervise programming of analyses, tables, listings, figures, and datasets, ensuring quality and timeliness.
14. Conduct quality control of statistical outputs.
15. Define analysis populations and programming criteria for their implementation.
16. Perform and supervise statistical analyses per study protocols and analysis plans.
17. Validate statistical methods and programs.
18. Manage clinical data to ensure security and confidentiality.
19. Produce statistical reports and contribute to study reports.
20. Collaborate with clinicians, researchers, operations, data management, and programmers.
21. Review and interpret analysis results for clinical reports.
22. Contribute to clinical development planning and sample size calculations.
23. Participate in international advisory boards.
24. Align departmental strategies with company goals.

Requirements

• Bachelor’s degree in Life Sciences or related fields.
• At least 5 years of biostatistics experience, particularly in oncology clinical trials, including Phase III studies.
• Experience designing Phase I-IV trials, including basket, umbrella, and adaptive trials.
• Proficiency in survival analysis methods and advanced statistical methodologies, including Bayesian methods and predictive modeling.
• Experience analyzing biomarker data, PROs, and composite endpoints.
• Proficiency in SAS and R; familiarity with Python, CDISC standards, and data management tools.
• Strong knowledge of regulatory guidelines and experience with regulatory interactions.