Senior Director Biostatistics

The Senior Director, Biostatistics is part of the Global Biometrics Department within Clinical Development and has full responsibility in managing the Biostatistics functional unit and will work according to company policies, SOPs and regulatory requirements.

Key responsibilities:

• Provide strategic leadership and direction to Biostatistics functional unit
• Responsibility together with VP Biometrics for budget and financial reporting for Statistics and Programming
• Operational System Owner as delegated
• Overall leadership and line management for assigned staff, including training, disciplinary procedures and administrative activities
• Ensure that global procedures such as Standard Operating Procedures are available, up to date and compliant with appropriate guidelines and legislation such as ICH, GCP and EU/US Directives
• Ensure that global operational deliverables are conducted in accordance to TFS quality standards
• Coach, support and mentor staff
• Conduct training as necessary, plus contribute to individual career development and goal
• Resource allocation, project staffing
• Review department utilization
• Recruitment of new staff
• P.A.R. behavior on performance review of Directors, Biostatistics
• Support the VP Biometrics in forecasting need for Statistics resources and communicating
• this to human resources and upper management
• Support the VP Biometrics in ensuring that all Statistical systems are validated and
• maintained in accordance to, industry best practice, regulatory requirements and guidelines
• Chair periodic functional meetings
• Budget cost and income, planning, monthly follow-up, annual follow-up
• Monthly invoicing, approval of time reports and travel expenses
• Preparation of proposals, follow-up, negotiation and preparation of contracts
• Ensure that new processes or process improvements are implemented within the unit
• Interact with senior management across disciplines
• Identify new and maintain current customers in cooperation with Marketing & Sales organization
• Accompany Marketing & Sales colleagues on customer visits and participate in presentations and bid defense meetings when required.
• Participate in the Biometrics Management meetings setting

Requirements

• Minimum of 13 years relevant statistical experience in pharmaceutical or CRO industry with increasing levels of responsibility
• Strong leadership skills
• Experience in project management, problem-solving and team leadership
• Ability to deal effectively with sponsors and internal customers at all levels
• Willingness and ability to travel on occasion
• Excellent verbal and written communication skills
• A Bachelor of Science (BSc) or Master’s Degree in statistics or equivalent; PhD in Statistics or related discipline preferred

Benefits

• Entrusted work time

• Fitness Contribution
• Health Insurance
• Life insurance
• Global General Liability Insurance
• Global Travel Insurance