Clinical Research Biostatistician

beBeeStatistician; Valencia; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

A leading clinical research organization in Spain is seeking a Clinical Trial Statistician to develop statistical methods and analyze data for clinical studies. The ideal candidate will ensure compliance with regulatory standards while collaborating with multidisciplinary teams. Strong experience in statistical design and analysis is required, along with the ability to present results effectively. This role is vital for informed decision-making within clinical trials.

Formación

• Experience in statistical design for clinical trials.
• Proficient in statistical analysis methods and reporting.
• Strong understanding of regulatory compliance in clinical statistics.

Responsabilidades

• Design and implement statistical methodologies for studies.
• Conduct statistical analysis and report results.
• Ensure compliance with regulatory standards.

Conocimientos

Statistical Design

Statistical Analysis

Data Validation

ANOVA

Regression

Survival Models

Descripción del empleo

Statistical Analyst Role

Our organization is seeking a Clinical Trial Statistician to contribute to the development of statistical methods and analysis strategies for clinical studies. The selected candidate will work closely with multidisciplinary teams to ensure compliance with regulatory standards and provide expert guidance on statistical design, analysis, and interpretation.

Key Responsibilities

• Statistical Design of the Clinical Trial
• Develop and implement statistical methodologies according to study protocols.
• Contribute to sample size determination and randomization strategies if applicable.
• Design analysis plans to evaluate efficacy and safety of treatments or medical devices.
• Statistical Analysis Plan (SAP) Development
• Write and review the SAP detailing all statistical methodologies used.
• Collaborate with other clinical and technical teams on SAP review and approval.
• Ensure the SAP aligns with regulatory requirements (FDA, EMA).
• Statistical Data Analysis
• Perform descriptive and inferential analyses to assess clinical trial results.
• Apply relevant statistical tests (ANOVA, regression, survival models, etc.).
• Generate reports and visualizations according to SAP specifications.
• Evaluate data consistency and validity through quality controls.
• MedDRA Coding and Adverse Event Analysis
• Apply MedDRA coding for adverse events and medical terms in studies.
• Validate correct adverse event classification and impact on safety analysis.
• Collaborate with physicians and pharmacovigilance teams for consistent coding.
• Statistical Reporting and CSR Preparation
• Prepare statistical reports with detailed presentation of results.
• Contribute to Clinical Study Report (CSR) preparation integrating statistical analysis.
• Present results clearly and accurately, facilitating clinical interpretation.
• Regulatory Compliance and Method Validation
• Ensure analyses comply with Good Clinical Practice (GCP) regulations.
• Support audits and regulatory reviews by providing statistical expertise.
• Document processes to ensure reproducibility and transparency of analysis.
• Expert Guidance and Decision Support
• Provide expert advice on statistical analysis results for informed decision-making within multidisciplinary teams.
• Propose adjustments or redesigns in statistical analyses based on preliminary results and study context.