Senior Director, Biostatistics - Immunology & Inflammation

Build our future together at Regeneron, where we use science and innovation to develop life-changing medicines for people with serious diseases.

About the Role

The Senior Director will lead our Biostatistics Immunology & Inflammation therapeutic area, responsible for strategic and operational activities. The incumbent will assist the Head of Biostatistics in developing and implementing departmental scientific policies, operational guidelines, and administrative structure. This role may also serve as a senior research expert and leader within Global Development for specific statistical methodology or application.

The successful candidate will have a track record in leading teams, structuring a function to manage growth in the product pipeline, and excellent communication skills to interface with senior leadership. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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-wide teams.
• Oversee the 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. 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. Harmonize policies with departmental guidelines, SOPs, and 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.
• Significant interaction with both FDA and EMEA.
• History of successful project and people management (6+ years).
• Expertise in multiple therapeutic areas.
• Active research interests in areas related to clinical trials.
• Demonstrated ability to work in a changing and busy environment, exercising judgment in interpreting, modifying, and adapting procedures, practices, and methods.
• Ability to work independently, self-directed, with high energy and strong work ethic. High degree of creativity, latitude, and attention to detail.
• 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.

Schedule

• 4 days per week on site (Tarrytown, NY, Cambridge, MA, or Warren, NJ).
• 25% travel may be required.

Pay

Salary Range (annually): $242,000.00 - $403,300.00.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits, 401(k) company match.
• Health and wellness programs, fitness centers.
• Insurance benefits (e.g., medical, dental, vision, life, and disability).
• Paid time off.
• Family support benefits.

For additional information about Regeneron benefits in the U.S., visit Regeneron Total Rewards. For other locations, additional information will be provided during the recruitment process.