Senior Director, Biostatistics - Immunology & Inflammation

About the role

Regeneron is seeking a Senior Director, Biostatistics to drive our Immunology and Inflammation therapeutic area.

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.
• Affirm 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.

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.
• History of successful project and people management (6+ years).
• Expertise in multiple therapeutic areas.
• 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.
• Demonstrated ability 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

• 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.
• History of successful project and people management (6+ years).
• Expertise in multiple therapeutic areas.
• 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.
• Demonstrated ability 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.

Skills

• Proven experience in determining department goals and resource allocation.
• Experience in ensuring project teams have high quality statistical support.
• Experience in working with senior management to ensure statistical representation in key project decisions and regulatory meetings.
• Experience in serving as departmental representative on corporate-wise teams.
• Experience in overseeing process for statistical reporting.
• Experience in reviewing critical documents and ensuring compliance with data submission guidelines.
• Experience in planning and tracking project activities, timelines, and resource use.
• Experience in providing justification for planned resource needs.
• Experience in seeking to optimize resource utilization across projects or areas.
• Experience in effecting long-range planning.
• Experience in ensuring technical direction and mentoring for staff.
• Experience in encouraging personal development in the context of project work.
• Experience in learning and applying techniques to promote teamwork, quality, and motivation.
• Experience in recruiting, developing, and retaining high quality staff.
• Experience in maintaining awareness of industry standards and regulatory requirements.
• Experience in alerting staff to new or changing standards.

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.

Pay

$242,000.00 - $403,300.00 annually

Schedule

Full-time