Principal Biostatistician

DNA Life Sciences; Madrid; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a skilled biostatistician to lead and contribute to innovative oncology clinical trials. In this role, you will leverage your expertise in biostatistics and statistical methodologies to oversee data analysis initiatives, develop statistical plans, and ensure alignment with strategic goals. You will collaborate with cross-functional teams and engage with stakeholders, making significant contributions to the design and execution of clinical studies. If you are passionate about advancing clinical research and thrive in a dynamic environment, this opportunity is perfect for you.

Formación

• 5+ years of biostatistics experience focused on oncology clinical trials.
• Proficiency in SAS and R for advanced statistical analysis.
• Leadership in cross-functional teams and mentorship of junior staff.

Responsabilidades

• Lead projects and oversee data analysis initiatives in clinical trials.
• Design and review statistical analysis plans and protocols.
• Participate in stakeholder meetings and contribute statistical expertise.

Conocimientos

Biostatistics

Oncology Clinical Trials

Statistical Analysis

Survival Analysis Methods

Bayesian Methods

Predictive Modeling

SAS

R

Patient-Reported Outcomes

Leadership

Educación

Bachelor's Degree in Life Science

Herramientas

SAS

R

Descripción del empleo

Responsibilities:

• Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
• Lead large projects involving complex project dynamics and ensuring alignment with strategic goals.
• Oversee data analysis initiatives; develop new methodologies and tools for data management.
• Participate in meetings with internal and external stakeholders in the discussion/defense of new study designs, contributing with data science expertise.
• Participate and oversee 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.
• Develop and/or oversee the Data Science Plan for assigned projects.
• Define or review randomization procedures and produce randomization lists.
• Develop and review 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 for the clinical study report.
• Contribute to clinical development plan preparation.
• Assist in performing/reviewing sample size calculations.
• Participate in international multi-stakeholder advisory boards.

Requirements:

• A bachelor’s degree in Life Science (Biology, Biotechnology, Biomedicine, Statistics, etc.).
• Minimum 5 years of experience in biostatistics, with a focus on oncology clinical trials, especially in Phase III studies.
• Experience in the design of Phase I-IV clinical trials, including basket, umbrella, and adaptive trials in oncology.
• Familiarity with 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.
• Strong presentation skills to defend trial designs and statistical analyses before medical, regulatory, 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.