P Are you a skilled b Clinical Trial Statistician /b 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? /p p 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. /p p 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. /p pb Key Accountabilities and Responsibilities: /b /p pb Statistical Design of the Clinical Trial /b /pulli Define the appropriate statistical methodology according to the study protocol. /lili Determine the optimal sample size and randomization of subjects if applicable. /lili Define analysis strategies to evaluate the efficacy and safety of the treatment/medical device. /li /ul pb Preparation of the Statistical Analysis Plan (SAP) /b /pulli Write the Statistical Analysis Plan (SAP) detailing all the statistical methodologies to be used. /lili Coordinate the review and approval of the SAP with other clinical and technical teams involved. /lili Ensure that the SAP complies with regulatory regulations (FDA, EMA). /li /ul pb Statistical Analysis of Clinical Data /b /pulli Perform descriptive and inferential analyses to evaluate clinical trial results. /lili Apply appropriate statistical tests (ANOVA, regression, survival models, etc.). /lili Generate tables, graphs, and lists according to SAP. /lili Evaluate the consistency and validity of the data through quality controls. /li /ul pb Coding and Analysis of Adverse Events (MedDRA) /b /pulli Apply MedDRA for coding adverse events and medical terms in the study. /lili Validate the correct classification of adverse events and their impact on safety analysis. /lili Coordinate with physicians and pharmacovigilance to ensure consistency in coding. /li /ul pb Statistical Reporting and CSR /b /pulli Write the statistical report of the study with the detailed presentation of the results. /lili Contribute to the preparation of the Clinical Study Report (CSR) integrating statistical analysis. /lili Present results in a clear and structured manner, facilitating their clinical interpretation and ensuring that information and results are clear, accurate, and understandable. /li /ul pb Regulatory Compliance and Method Validation /b /pulli Ensure that analyses comply with Good Clinical Practice (GCP) regulations. /lili Collaborate on audits and regulatory reviews by providing statistical support. /lili Document processes to ensure reproducibility and transparency of analysis. /li /ul pb Advice on Data Interpretation and Decision Making: /b /pulli Provide expert advice on the results of statistical analyses to facilitate decision-making within multidisciplinary teams (medical, scientific, regulatory, etc.). /lili 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. /li /ul pb Academic Background: /b /pulli University degree in Statistics, Mathematics, Biostatistics, or related. /lili A PhD or a comparable work experience in statistics applied to clinical trials. /li /ul pb Work Experience: /b /pullib Minimum 3 years of experience in statistics applied to clinical trials, with practical experience in managing several projects. /b /lili Verifiable experience in the development of SAP, statistical final reports and CSRs in clinical trials. /lili Management of adverse event coding using MedDRA and knowledge of other classifications such as CTCAE. /lili Familiarity with international regulatory standards and statistical reporting requirements. /li /ul pb Technical Skills: /b /pulli Mastery of statistical tools such as SAS, R, SPSS or other programs used in the pharmaceutical industry. /lili In-depth knowledge of experimental design, multivariate analysis and advanced statistical techniques. /lili Experience or Knowledge in clinical trials with Bayesian design will be valued. /lili Experience in validating data and executing data quality controls. /li /ul pb Soft Skills: /b /pulli Excellent project management, organization, task prioritization, and technical report writing skills. /lili Clear communication skills, both written and verbal, to interact with multidisciplinary teams. /lili Ability to work under pressure and manage multiple projects simultaneously. /lili Attention to detail and rigor in data validation. /li /ul pb We offer: /b /p ulli Full package with attractive salary conditions based on the candidate#39;s skills, experience, and suitability once selected. /lili Flexible working hours and hybrid work mode. /lili Future working trajectory within the Foundation. /lili22 vacation days, 2 personal leave days and 2 “pink days” (working hours adjustment). /lili Internal training opportunities and a collaborative research environment. /lili Access to flexible compensation program (meal, nursery, transport vouchers, health insurance). /lili On-site childcare program during school holidays. /lili Free coffee, snacks and kitchen essentials. /lili Gym partnership at reduced rate. /lili Team events: summer dinner, holiday celebration, paella contest. /li /ul