Are you a skilled Clinical Trial Statistician eager to contribute your expertise to advancing women’s health? Do you want to apply your statistical knowledge to the design, analysis, and interpretation of clinical trials that could improve the quality of life and reproductive health of women worldwide?
At the Carlos Simon Foundation, we are at the forefront of research in reproductive medicine and women’s health, and we are looking for talented professionals to join our multidisciplinary team.
As a Clinical Trial Statistician at the Carlos Simon Foundation, you will play a pivotal role in shaping the statistical design of clinical studies, developing analysis strategies, ensuring compliance with international regulatory standards, and providing expert guidance to multidisciplinary 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.
Key Accountabilities and Responsibilities:
Statistical Design of the Clinical Trial
- Define the appropriate statistical methodology 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 the 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 the 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 their clinical interpretation and ensuring that information and results are clear, accurate, and understandable.
Regulatory Compliance and Method Validation
- Ensure that analyses comply with Good Clinical Practice (GCP) 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 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. To perform Interim Analysis if applicable.
Academic Background:
- University degree in Statistics, Mathematics, Biostatistics, or related.
- A PhD or a 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 will be 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.
We offer:
- Full package with attractive salary conditions based on the candidate's skills, experience, and suitability once selected.
- Flexible working hours and hybrid work mode.
- Future working trajectory within the Foundation.
- 22 vacation days, 2 personal leave days and 2 “pink days” (working hours adjustment).
- Internal training opportunities and a collaborative research environment.
- Access to flexible compensation program (meal, nursery, transport vouchers, health insurance).
- On-site childcare program during school holidays.
- Free coffee, snacks and kitchen essentials.
- Gym partnership at reduced rate.
- Team events: summer dinner, holiday celebration, paella contest.
