Data-Driven Statistician for Clinical Trials

beBeeClinical; Valencia; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A healthcare research organization in Valencia is seeking a Statistical Analyst for Clinical Trials. The ideal candidate will have a degree in Statistics and at least 3 years of experience in clinical trial statistics. Responsibilities include defining statistical methodologies, coding adverse events, and ensuring compliance with regulatory standards. The position offers flexible working hours and competitive salary conditions based on skills and experience.

Servicios

Flexible working hours

Hybrid work mode

Attractive salary conditions

Formación

• Minimum 3 years of experience in statistics applied to clinical trials.
• Verifiable experience in developing SAP and statistical reports.
• Management of adverse event coding using MedDRA.

Responsabilidades

• Define statistical methodology and sample size for studies.
• Apply MedDRA for coding adverse events.
• Ensure compliance with Good Clinical Practice (GCP) regulations.

Conocimientos

Statistical methodology

Coding adverse events

Regulatory compliance

Statistical tools (SAS, R, SPSS)

Data quality control

Educación

University degree in Statistics or related

PhD or comparable work experience

Herramientas

SAS

R

SPSS

Descripción del empleo

Overview

Statistical Analyst for Clinical Trials

We are seeking a skilled Statistical Analyst to join our research team. As a key member of our multidisciplinary team, you will play a pivotal role in shaping the statistical design of clinical studies, developing analysis strategies, and ensuring compliance with international regulatory standards.

Key Responsibilities

• Statistical Design: Define the appropriate statistical methodology according to the study protocol, determine the optimal sample size and randomization of subjects if applicable, and define analysis strategies to evaluate the efficacy and safety of the treatment / medical device.
• 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, and coordinate with physicians and pharmacovigilance to ensure consistency in coding.
• 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, and provide expert advice on the results of statistical analyses to facilitate decision-making within multidisciplinary teams.

Requirements

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

Preferred 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.
• Experience in validating data and executing data quality controls.

About Our Organization

Our organization is committed to advancing women's health through research and innovation. We offer a dynamic and collaborative research environment, flexible working hours, hybrid work mode, and a range of benefits including attractive salary conditions based on the candidate's skills, experience, and suitability once selected.