Senior Biometrics Director

3 weeks ago

Mississauga, Ontario, Canada Ergomed Full time
Job Overview

We are seeking a highly experienced Senior Biometrics Director to lead our global Biometrics department. As a key member of our Leadership Team, you will be responsible for overseeing the strategic direction and operational delivery of our biostatistics, programming, data management, and medical writing teams.

The ideal candidate will have a strong track record of driving and executing biometrics strategy, with a deep understanding of the drug development process, worldwide regulatory requirements, clinical trial methodology, and complex statistical designs.

Key responsibilities will include:

  • Providing strategic leadership and mentorship to the biostatistics, data management, and medical writing teams
  • Developing and maintaining a high-performing, collaborative, and results-oriented department
  • Developing core competencies of the group, fostering a culture of continuous improvement and innovation within the team
  • Developing infrastructure/processes and best practices for the function
  • Ensuring high quality of all services and deliverables provided by Biometrics
  • Monitoring progress of projects against budget for Biometrics
  • Developing benchmarks for tasks re time, budget, quality
  • Responsible for functional resource allocation; assign functional resources for each project based on scope of services in the proposal/contract; supervise to ensure timely and quality delivery of the service and provide guidance and support to the functional representative on each project as needed
  • Responsible for budget, forecast and profitability of the functional services for each project
  • Provides strategic consulting to clients on their product development strategy, including development options, statistical study design, specification of endpoints, and sample size determination/justification
  • Actively participates in Business Development (BD) process as a subject matter expert by providing strategic and tactical input at bid defenses
  • Participates in the generation of proposals
  • Represents the Company by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals
Requirements
  • Degree qualified in a Biometrics/Life Science related subject
  • Demonstrated experience working in a CRO environment leading a global biometrics team including statistics, programming, data management and medical writing
  • Record of driving and executing biometrics strategy
  • In depth knowledge of the drug development process, worldwide regulatory requirements, clinical trial methodology and complex statistical designs
  • Excellent leadership and management skills
  • Demonstrated ability to lead cross-functional teams
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment
  • Effective organizational, presentation, documentation and interpersonal skills
  • Effective problem solving and decision making
  • Exceptional communication skills and the ability to collaborate effectively with internal and external stakeholders
  • Strong customer focus
About Ergomed

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

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