Head of Biostatistics (Pharmaceutical, Onsite)

Job summary

The Head of Biostatistics will lead the biostatistics function, providing scientific and operational leadership across clinical development programs. This role involves defining and executing the biostatistics strategy, ensuring compliance with global regulatory standards, and guiding trial design and methodology. The position requires strong people leadership skills to build and develop a team of skilled Biostatisticians.

Qualifications

• Master’s degree or PhD in statistics or mathematics
• Proven experience in people leadership within a matrix, cross-functional environment
• Extensive background in biostatistics, particularly in the biotech or pharmaceutical industry
• 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 to the Biostatistics team
• Coach and develop team members, enhancing their capabilities
• Shape and implement biostatistics strategy throughout the development value chain
• Oversee clinical development plans and evidence generation for decision-making
• Manage resource planning, outsourcing strategies, and vendor oversight
• Guide the preparation of briefing documents and regulatory submissions
• Collaborate closely with other departmental heads, including Medical & Science, Clinical Operations, and Regulatory Affairs

Skills

• Strong leadership and team-building skills
• Excellent problem-solving and analytical abilities
• Effective communication and interpersonal skills
• Ability to work collaboratively in a complex environment

Education

• Advanced degree in statistics or mathematics required

Tools

• Familiarity with statistical software and methodologies relevant to clinical trials