Head of Biometry

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.

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

EXPERIENCE

LANGUAGES

CORE COMPETENCIES & SKILLS

WORKING CONDITIONS