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IQVIA Principal Biostatistician (FSP - Permanent Homebased) in Madrid, Spain

Job Description:

The Principal Statistician will be responsible for developing and maintaining standard statistical requirements in data analysis tools and templates, ensuring compliance with industry standards and health authority regulations. These requirements will be aligned with therapeutic area needs and study design considerations.

Key Responsibilities:

  • Develop and maintain standard statistical requirements, including text, definitions, and analysis requirements for Protocols and Statistical Analysis Plans.

  • Create standard tables, listings, and graph mock displays with detailed analysis requirements and rules in Data Presentation Specifications.

  • Maintain data analysis standards at a master level to meet scientific or operational requirements, ensuring formal change management control and versioning.

  • Govern changes to standards, maintaining multiple versions to align with clinical trials and drug development programs.

  • Support the clinical data standards team and standards implementation leads to ensure consistent adoption of standards in studies.

  • Expertise in experimental design, modeling, analysis planning, execution, interpretation, and statistical communications support.

  • Produce clear, concise, well-organized, and error-free analysis programs and statistical reporting content.

  • Establish and maintain effective relationships with internal and external customers.

Educational and Experience Requirements:

  • Master’s or PhD Degree in Statistics.

  • Expertise in SAS or R programming.

  • Working knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., ADaM).

  • Relevant operational experience in analysis standards is preferred.

  • Experience in multiple therapeutic areas (e.g., Oncology, Cardiovascular, Immunology, Medical Devices, Neuroscience) is preferred.

  • Ability to work independently with minimal oversight.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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