Director, Biostatistics Genetics Medicine

Regeneron Pharmaceuticals • Tarrytown, NY

4d • Onsite

About The Position

Regeneron is seeking a Director, Biostatistics to join our team! This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. This position requires an individual with a strong background in biostatistics, exceptional leadership capabilities, and the ability to contribute meaningfully to drug development and regulatory strategies while fostering collaboration and innovation across teams. Please note: This is a 4 day onsite opportunity on a weekly cadence. If you are not local and qualify, Regeneron can offer a relocation package. This role might be for you if can/have Lead and/or oversee the efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints, and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to interpret the results and make decisions appropriately. The incumbent will work with Strategic Project Teams on clinical and regulatory strategies for the clinical development strategy and will represent statistical issues in regulatory agency meetings. The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications. As a Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians and working with those statisticians to ensure other programs are properly supported, with the potential to manage full-time staff. In this role, a typical day might include: Cross-Functional Collaboration: Represent Biostatistics in Strategic Project Teams and Global Clinical Sub teams Partner with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical Scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze clinical trials. Ensure clinical programs are appropriately structured for success. Regulatory Contributions: Guide staff in preparing materials for regulatory interactions, including analysis plans, tables, figures, and listings (TFLs) for submissions and advisory committee meetings. Co-present findings to regulatory agencies and management. Process and Methodology Development: Identify gaps in processes and lead working groups to implement improvements. Develop and revise SOPs and contribute to cross-functional workstreams. Lead research teams to establish new statistical methodologies as needed. Communication and Training: Prepare presentations and reports to effectively communicate statistical findings to project teams, management, and regulatory bodies. Deliver training programs to enhance statistical understanding among non-statistical colleagues. Leadership and Mentorship: Mentor and oversee junior statisticians, ensuring adequate support for other programs. Potentially manage full-time staff and oversee their professional development.

Requirements

• PhD in Statistics/Biostatistics with over 8 years of pharmaceutical industry experience (or MS in Statistics/Biostatistics with over 13 years).
• In-depth knowledge of drug discovery and development, with the ability to integrate statistical concepts into strategic decision-making.
• Strong leadership and influence skills, with a proven ability to collaborate effectively in cross-functional teams.
• Demonstrated critical thinking, time management, and communication skills to thrive in a fast-paced, collaborative environment.

Nice To Haves

• A PhD is strongly preferred.
• Preferred experience in the fields of rare disease, neurodegenerative disease or gene therapy.

Responsibilities

• Lead and/or oversee the efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints, and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to interpret the results and make decisions appropriately.
• Work with Strategic Project Teams on clinical and regulatory strategies for the clinical development strategy and will represent statistical issues in regulatory agency meetings.
• Lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications.
• Mentor and oversee less experienced statisticians and working with those statisticians to ensure other programs are properly supported, with the potential to manage full-time staff.
• Represent Biostatistics in Strategic Project Teams and Global Clinical Sub teams
• Partner with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical Scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze clinical trials.
• Ensure clinical programs are appropriately structured for success.
• Guide staff in preparing materials for regulatory interactions, including analysis plans, tables, figures, and listings (TFLs) for submissions and advisory committee meetings.
• Co-present findings to regulatory agencies and management.
• Identify gaps in processes and lead working groups to implement improvements.
• Develop and revise SOPs and contribute to cross-functional workstreams.
• Lead research teams to establish new statistical methodologies as needed.
• Prepare presentations and reports to effectively communicate statistical findings to project teams, management, and regulatory bodies.
• Deliver training programs to enhance statistical understanding among non-statistical colleagues.

Benefits

• comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
• relocation package

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees