Clinical Trial Statistician Position

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

Descripción de la vacante

A healthcare analytics firm in Valencia is seeking a Statistical Analyst for Clinical Trials to contribute to women's health research. You will develop statistical designs, create analysis plans, and ensure compliance with regulatory standards. Ideal candidates should have a degree in a relevant field, a PhD or equivalent experience, and at least 3 years in clinical statistics, preferably with familiarity in Bayesian design. Strong knowledge of SAS, R, and SPSS is required. This role offers competitive compensation and an opportunity to make an impact in healthcare.

Formación

• Minimum 3 years of experience in statistics applied to clinical trials.
• Experience in developing SAPs and statistical reports.
• Knowledge of regulatory standards for clinical trials.

Responsabilidades

• Develop a statistical design for clinical trials.
• Create a Statistical Analysis Plan (SAP) and ensure compliance.
• Perform descriptive and inferential analyses.

Conocimientos

Statistical design

Statistical analysis

SAS

R

SPSS

MedDRA coding

Educación

University degree in Statistics, Mathematics, Biostatistics or related field

PhD or equivalent work experience

Herramientas

SAS

R

SPSS

Descripción del empleo

Overview

Statistical Analyst for Clinical Trials

Contribute to the advancement of women's health by applying statistical knowledge in clinical trials.

Key Responsibilities

• Develop a statistical design for clinical trials, including methodology definition, sample size determination, and analysis strategies.
• Create a Statistical Analysis Plan (SAP) detailing methodologies and ensure compliance with regulatory requirements.
• Perform descriptive and inferential analyses, apply statistical tests, and generate tables, graphs, and lists according to SAP.
• Code and analyze adverse events using MedDRA, validate correct classification, and coordinate with physicians and pharmacovigilance.
• Write statistical reports and contribute to the Clinical Study Report (CSR), presenting results clearly and concisely.
• Ensure analyses comply with Good Clinical Practice (GCP) regulations, collaborate on audits and regulatory reviews, and document processes for reproducibility and transparency.

Requirements

• University degree in Statistics, Mathematics, Biostatistics, or a related field.
• PhD or equivalent 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 developing 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 include mastery of statistical tools like SAS, R, SPSS, or other programs used in the pharmaceutical industry. Experience or knowledge in clinical trials with Bayesian design is valued.