Clinical trial Statistician - Paterna - Carlos Simon Foundation for Research in Women's Health

Descripción

About the Carlos Simon Foundation for Research in Women's Health

The Carlos Simon Foundation is a non-profit organization dedicated to creating a world where women's health pathologies affecting the uterus no longer hinder their quality of life and reproductive desires. Our main activity is biomedical research in reproductive medicine and women's health, and the development of initiatives aimed at improving our knowledge in the field and its application.

We are affiliated with the University of Valencia and the INCLIVA Health Research Institute (IIS INCLIVA), accredited by the Carlos III Health Institute, promoting educational access for our students and fostering the careers of our research team.

Key Responsibilities:

Statistical Design of Clinical Trials

• Define appropriate statistical methodologies according to the study protocol.
• Determine the optimal sample size and randomization of subjects if applicable.
• Define analysis strategies to evaluate the efficacy and safety of the treatment/medical device.

Preparation of the Statistical Analysis Plan (SAP)

• Write the Statistical Analysis Plan (SAP) detailing all statistical methodologies to be used.
• Coordinate the review and approval of the SAP with other clinical and technical teams involved.
• Ensure that the SAP complies with regulatory regulations (FDA, EMA).

Statistical Analysis of Clinical Data

• Perform descriptive and inferential analyses to evaluate clinical trial results.
• Apply appropriate statistical tests (ANOVA, regression, survival models, etc.).
• Generate tables, graphs, and lists according to SAP.
• Evaluate the consistency and validity of the data through quality controls.

Coding and Analysis of Adverse Events (MedDRA)

• Apply MedDRA for coding adverse events and medical terms in the study.
• Validate the 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 the statistical report of the study with detailed presentation of the results.
• Contribute to the preparation of the Clinical Study Report (CSR) integrating statistical analysis.
• Present results in a clear and structured manner, facilitating clinical interpretation and ensuring information and results are clear, accurate, and understandable.

Regulatory Compliance and Method Validation

• Ensure analyses comply with Good Clinical Practice (GCP) regulations.
• Collaborate on audits and regulatory reviews providing statistical support.
• Document processes to ensure reproducibility and transparency of analysis.

Advice on Data Interpretation and Decision Making:

• Provide expert advice on the results of statistical analyses to facilitate decision-making within multidisciplinary teams (medical, scientific, regulatory, etc.).
• Propose adjustments or redesigns in statistical analyses as studies progress, considering preliminary results and the context of the clinical trial. Perform Interim Analysis if applicable.

Required skills and experience:

Academic Background:

• University degree in Statistics, Mathematics, Biostatistics, or related.
• PhD or comparable work experience in statistics applied to clinical trials.

Work Experience:

• Minimum 3 years of experience in statistics applied to clinical trials, with practical experience in managing several projects.
• Verifiable experience in the development of SAP, statistical final reports, and CSRs in clinical trials.
• Management of adverse event coding using MedDRA and knowledge of other classifications such as CTCAE.
• Familiarity with international regulatory standards and statistical reporting requirements.

Technical Skills:

• Mastery of statistical tools such as SAS, R, SPSS, or other programs used in the pharmaceutical industry.
• In-depth knowledge of experimental design, multivariate analysis, and advanced statistical techniques.
• Experience or knowledge in clinical trials with Bayesian design valued.
• Experience in validating data and executing data quality controls.

Soft Skills:

• Excellent project management, organization, task prioritization, and technical report writing skills.
• Clear communication skills, both written and verbal, to interact with multidisciplinary teams.
• Ability to work under pressure and manage multiple projects simultaneously.
• Attention to detail and rigor in data validation.

Labor conditions:

Salary:

• Salary range will depend on the candidate's previous track records and suitability for the requested profile.

• Full-time employment contract.

What we offer:

• Participate in a research project framed within women's health in a highly motivating team.

• Opportunity for professional and personal growth.