Head of Data Management & Statistics

The Head of Biometry 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., · 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., Clinical Administrator Clinical Development Clinical Operations Clinical Program Manager Clinical Project Manager Clinical Research Associate Clinical Research Nurse Clinical Research Scientist Clinical Services Clinical Study Manager Clinical Supplies Clinical Trials Manager / Administrator Drug Safety Feasibility Investigator Patient Recruitment Pharmacoeconomics Pharmacovigilance Study Site Coordinator Study Start Up

Data Management / Statistics

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Biostatistics Clinical Data Management Data Analyst Informatics SAS Programming Statistical Programming Statistics

Finance / Administration

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Healthcare

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Carer / Healthcare Assistant Consultant General Practitioner Nurse Pharmacy Physician / Doctor, Biology Biotechnology Chemistry Epidemiology Genetics and Genomics Laboratory Pharmacokinetics Pharmacology Pre - clinical Proteomics Scientific Toxicology

Regulatory Affairs

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CMC Compliance Labelling Regulatory Writing

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· 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

· Full time position

· Office located in Barcelona

· Hybrid work (minimum of two days in the office / week)

· Competitive salary