Senior Director, Biostatistics - Immunology & Inflammation

About the role

The Senior Director, Biostatistics will lead the Immunology and Inflammation therapeutic area at Regeneron Pharmaceuticals, Inc.

Responsibilities

• Determine Department goals and resource allocation in conjunction with the Department Executive Director.
• Ensure project teams have high quality statistical support for creation of clinical development plans, study design, and operational aspects.
• Work with senior management to ensure statistical representation in key project decisions and regulatory meetings. Serve as departmental representative on corporate-wise teams.
• Oversee process for statistical reporting. Review critical documents, such as SAP, analysis results presentations, CSR, and integrated summaries. Ensure compliance with data submission guidelines.
• Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization across projects or areas. Effect long-range planning.
• Ensure technical direction and mentoring for staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Recruit, develop, and retain high-quality staff.
• Maintain awareness of industry standards and regulatory requirements. Alert staff to new or changing standards. Within area of control, harmonize policies with departmental guidelines, SOPs, and with industry standards. Develop policies promoting application of corporate values in work practices.

Requirements

• Ph.D. in statistics or related discipline with 10+ years of experience (or MS in statistics or related discipline with 15+ years) in the biotechnology, pharmaceutical, or health-related industry, including significant interaction with both FDA and EMEA.
• Active research interests in area related to clinical trial.
• Demonstrated ability to work in a changing and busy environment and to exercise judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
• Ability to work independently, self-directed, high energy, and strong work ethic. High degree of creativity, latitude, and attention to detail required.
• Demonstrated strong leadership, project management, teamwork, and interpersonal skills.
• Excellent presentation skills.
• Experience and proven ability leading and managing major process and technology initiatives with utilization and impact across multiple functional groups.
• Broad knowledge and superior understanding of advanced statistical concepts and techniques.
• Outstanding ability and skills to effectively represent Biostatistics and Data Management in interactions with senior management or cross-functional committees.
• Thorough knowledge of pharmaceutical clinical development and life cycle management; ability to innovatively apply technical principles, theories, and concepts to clinical drug development leading to regulatory approvals.
• Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
• Understanding of the drug discovery and development process, regionally and globally.
• Strong administrative skills.
• Ability to influence others to achieve results.

Qualifications

• Proven experience determining Department goals and resource allocation.
• Experience ensuring project teams have high quality statistical support.
• Experience working with senior management on statistical representation in key project decisions and regulatory meetings.
• Experience overseeing statistical reporting processes.
• Experience planning and tracking project activities, timelines, and resource use.
• Experience ensuring technical direction and mentoring for staff.
• Experience maintaining awareness of industry standards and regulatory requirements.
• Experience leading and managing major process and technology initiatives.
• Experience with broad knowledge and superior understanding of advanced statistical concepts and techniques.
• Experience representing Biostatistics and Data Management in interactions with senior management or cross-functional committees.
• Experience with thorough knowledge of pharmaceutical clinical development and life cycle management.
• Experience with strong administrative skills.
• Experience influencing others to achieve results.