Head of Biostatistics (Pharmaceutical, Onsite)

Job summary

The Head of Biostatistics will lead the biostatistics function, providing scientific and operational guidance for clinical trials. This role involves defining and executing biostatistics strategies, ensuring compliance with global regulatory standards, and developing a skilled team of biostatisticians.

Qualifications

• Master’s degree or PhD in statistics or mathematics
• Proven leadership experience in a matrix, cross-functional environment
• Extensive background in biostatistics within the biotech or pharmaceutical sector
• Experience with regulatory submissions and interactions
• Proficiency in statistical methodologies and tools used in clinical development
• Strong communication and stakeholder management abilities
• Capacity to influence senior leadership
• Commitment to high standards of quality, integrity, and compliance

Responsibilities

• Provide daily leadership and support for the biostatistics team
• Coach and develop team members, enhancing their capabilities
• Shape biostatistics strategy throughout the development value chain
• Guide clinical development plans and evidence generation for decision-making
• Oversee resource planning, outsourcing strategies, and vendor management
• Advise on briefing documents and regulatory submissions
• Collaborate closely with heads of other departments such as Medical & Science, Clinical Operations, and Regulatory Affairs

Skills

• Strong leadership and team-building skills
• Ability to operate effectively in a complex, cross-functional environment
• Excellent analytical and problem-solving skills
• High level of scientific judgment and clarity in communication

Education

• Advanced degree (Master’s or PhD) in relevant fields such as statistics or mathematics

Tools

• Familiarity with statistical software and methodologies relevant to clinical trials