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Senior Biometrics Director

1 month ago

Reading, Reading, United Kingdom ICON plc Full time
Job Title: Senior Biometrics Director

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Summary:

The Senior Biometrics Director will oversee critical functions, including pharmacovigilance, medical writing, and regulatory affairs, with a focus on driving excellence from a functional service provider (FSP) perspective.

Key Responsibilities:
  1. Manage regional functional projects to ensure high standards of client satisfaction, quality, efficiency, and adherence to timelines and budgets.
  2. Regularly liaise with clients and senior management to ensure ongoing client satisfaction, addressing issues promptly.
  3. Keep executive management informed of project status, including budget, personnel, quality, and timelines through monthly reports.
  4. Collaborate with other managers and departments to improve organizational efficiency, effectiveness, and regulatory compliance.
  5. Provide leadership and direction to functional personnel, including hiring, training, and performance evaluation.
  6. Prepare and manage departmental budgets, instituting cost control measures and notifying management of any financial concerns.
  7. Supervise the planning, acquisition, and implementation of systems and development of Standard Operating Procedures (SOPs) to meet organizational needs.
  8. Ensure effective staff management, accountability, and the maintenance of the company's culture and values.
Requirements:
  1. Extensive experience in the pharmaceutical, biotechnology, or CRO industry, with significant leadership experience in biometrics, including biostatistics, programming, data management, and statistical programming.
  2. In-depth understanding of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH) and experience in leading teams through regulatory submissions and interactions.
  3. Strong track record of managing complex, large-scale projects, including ensuring timelines, budgets, and quality standards are met.
  4. Experience working with global clients, including managing client relationships, ensuring client satisfaction, and supporting business development efforts.
  5. Deep understanding of statistical methodologies, clinical trial design, and data analysis techniques, with experience in various statistical software and tools (e.g., SAS, R).
  6. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams, executive management, and external clients.
What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a Global Employee Assistance Programme.