Head of Data Management & Statistics

Private Foundation Món Clínic Barcelona; Córdoba; Híbrido; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A prominent clinical research organization in Córdoba is looking for a Head of Data Management & Statistics. The role involves overseeing data management, ensuring compliance with clinical study protocols, and leading biometrics activities. Candidates should have a PhD in relevant fields and a strong background in statistical analysis and clinical trials. This full-time position offers a hybrid work environment, with competitive salary and opportunities for advancement.

Servicios

Competitive salary

Hybrid work model

Formación

• Strong knowledge of statistical analysis methodologies, experimental design and clinical trial expertise.
• Solid understanding of Good Clinical Practice.
• Knowledge of clinical studies regulatory framework.

Responsabilidades

• Define and execute the strategy for Data Management and Statistics.
• Supervise Data Management Manager & Statistics Manager.
• Lead biometrics activities including biostatistics and clinical data management.
• Manage budgets, resources, and timelines.
• Ensure quality and reliability of clinical data and systems.

Conocimientos

Statistical analysis methodologies

Experimental design

Leadership

Project management

Communication

Educación

PhD in Biostatistics, Statistics, Mathematics, Data Science

Descripción del empleo

The Head of Data Management & Statistics is responsible for defining and executing the strategy, as well as managing the resources within the Data Management and Statistics departments, to ensure the proper design, validation, implementation, maintenance, and close-out of electronic Case Report Forms (eCRFs) in compliance with clinical study protocols and regulatory requirements. He or she is also accountable for the appropriate planning and execution of relevant risk-based Data Management activities.

MAIN RESPONSIBILITIES

• Reports to the Director of Operations.
• Supervise and reporting line of Data Management Manager & Statistics Manager
• Lead and oversee all biometrics activities (in-house and outsourced), including biostatistics, statistical programming, and clinical data management.
• Develop and implement strategic directions for the department in accordance with the global BCCC strategy.
• Manage budgets, resources and timelines.
• Ensure the quality, accuracy, and reliability of clinical data and systems.
• Establish and maintain the standards, policies, and procedures for the department in accordance with the Quality Management System of BCCC.
• Accountable for all data management and statistics deliverables.
• Keeps abreast of new developments in clinical data collection, processing, storage, and retrieval to provide guidance in the selection, enhancement and maintenance of data management tools and processes.
• Manage vendors for systems and software used by Data Management and Statistics teams.
• Serve as Project Manager for studies with only Data Management and / or Statistics services contracted.
• Ensure all deliverables are on time and on budget for all data management projects.
• Collaborate with cross-functional teams to support clinical development and regulatory submissions.
• Provide statistical input into clinical development plans, study designs and data analysis.

REQUIRED QUALIFICATION

• Education (formal learning) – PhD in Biostatistics, Statistics, Mathematics, Data Science or a related field.
• Strong knowledge of statistical analysis methodologies, experimental design and clinical trial expertise.
• Solid understanding of Good Clinical Practice.
• Knowledge of clinical studies regulatory framework.
• Knowledge of applicable data protection regulation.

EXPERIENCE

• Proven leadership experience in biometry within the biotechnology or pharmaceutical sector, typically acquired over 8+ years, though strong candidates with less experience and exceptional impact will also be considered.
• Extensive experience designing and analysing clinical trials, field studies or experimental programs.

LANGUAGES

• Advanced English level. Desirable at least and advanced Spanish or Catalan level.

CORE COMPETENCIES & SKILLS

• Competence in software and hardware tools used in Data Management and Statistics processes.
• Familiarity with system validation, execution and documentation.
• Strong leadership, strategic thinking and communication skills.
• Strong project management and organizational skills.

WORKING CONDITIONS

• Full time position
• Offices located in Barcelona
• Hybrid work (minimum of two days in the office)
• Competitive salaryStarting date of the contract : October / November 2025