Clinical Research Statistician

beBeeClinicalResearch; Valencia; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A clinical research organization based in Valencia is seeking a Clinical Research Statistician to advance women's health through statistical expertise. You will design and analyze clinical trials, ensuring compliance with regulatory standards and providing statistical guidance. Ideal candidates have a PhD in relevant fields and at least 3 years of experience in clinical trial statistics. This position offers a competitive salary and flexible working conditions.

Servicios

Flexible working hours

Hybrid work mode

Attractive salary conditions

Formación

• PhD or comparable work experience in statistics applied to clinical trials.
• Minimum 3 years of experience in statistics applied to clinical trials.
• Familiarity with international regulatory standards.

Responsabilidades

• Define appropriate statistical methodology according to the study protocol.
• Write SAP detailing all statistical methodologies to be used.
• Perform descriptive and inferential analyses to evaluate clinical trial results.
• Apply MedDRA for coding adverse events and medical terms in the study.
• Write statistical report of the study with detailed presentation of results.

Conocimientos

Statistical analysis

Clinical trial methodology

Statistical reporting

Regulatory compliance

Data interpretation

Educación

PhD in Statistics, Mathematics, or Biostatistics

Descripción del empleo

Clinical Research Statistician

Advance Women's Health Research through Statistical Expertise.

We are seeking a skilled statistician to contribute their statistical knowledge in designing, analyzing, and interpreting clinical trials that could improve the quality of life and reproductive health of women worldwide.

This is an opportunity to be part of our multidisciplinary team shaping the statistical design of clinical studies, developing analysis strategies, ensuring compliance with international regulatory standards, and providing expert guidance to teams.

Your work will directly impact the scientific rigor and clinical relevance of our trials, supporting our mission to remove barriers to women's health and reproductive desire.

Main Responsibilities

• Statistical Design of Clinical Trials: Define appropriate statistical methodology according to the study protocol. Determine optimal sample size and randomization of subjects if applicable. Define analysis strategies to evaluate efficacy and safety of treatments / medical devices.
• Preparation of Statistical Analysis Plan (SAP): Write SAP detailing all statistical methodologies to be used. Coordinate review and approval of SAP with other clinical and technical teams involved. Ensure SAP complies with regulatory regulations.
• Statistical Analysis of Clinical Data: Perform descriptive and inferential analyses to evaluate clinical trial results. Apply appropriate statistical tests. Generate tables, graphs, and lists according to SAP. Evaluate consistency and validity of data through quality controls.
• Coding and Analysis of Adverse Events (MedDRA): Apply MedDRA for coding adverse events and medical terms in the study. Validate correct classification of adverse events and their impact on safety analysis. Coordinate with physicians and pharmacovigilance to ensure consistency in coding.
• Statistical Reporting and CSR: Write statistical report of the study with detailed presentation of results. Contribute to preparation of Clinical Study Report integrating statistical analysis. Present results in clear and structured manner facilitating clinical interpretation.
• Regulatory Compliance and Method Validation: Ensure analyses comply with Good Clinical Practice regulations. Collaborate on audits and regulatory reviews by providing statistical support. Document processes to ensure reproducibility and transparency of analysis.
• Advice on Data Interpretation and Decision Making: Provide expert advice on results of statistical analyses to facilitate decision-making within multidisciplinary teams. Propose adjustments or redesigns in statistical analyses considering preliminary results and context of clinical trial.

Required Skills and Qualifications

• University degree in Statistics, Mathematics, Biostatistics, or related field. PhD or comparable work experience in statistics applied to clinical trials.
• Minimum 3 years of experience in statistics applied to clinical trials, managing several projects. Verifiable experience in development of SAP, statistical final reports, and CSRs in clinical trials.
• Familiarity with international regulatory standards and statistical reporting requirements.

Benefits

• A full package with attractive salary conditions based on candidate's skills, experience, and suitability once selected. Flexible working hours and hybrid work mode. Future working trajectory within the organization.