Director, Biostatistics - Obesity

Regeneron Pharmaceuticals•Warren, MI

10d

About The Position

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. This role might be for you if can: 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 Global Clinical Subteams. 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. A PhD is strongly preferred.
MS in Statistics/Biostatistics with over 13 years of pharmaceutical industry experience.
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

Preferred experience in the fields of obesity, cardiovascular, and/or metabolism.

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 junior statisticians, ensuring adequate support for other programs
Potentially manage full-time staff
Represent Biostatistics in Global Clinical Subteams
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

We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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