Overview
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 role requires 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 is a four-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 you can/have the following qualifications and capabilities.
Responsibilities
- Lead and/or oversee the Biostatistics department with cross-functional teams to articulate drug development questions, assess endpoint feasibility, and frame statistical approaches to address those questions.
- Design clinical experiments and interventional studies to generate and analyze data, and collaborate with teams to interpret results and inform decisions.
- Work with Strategic Project Teams on clinical and regulatory strategies for the clinical development strategy and 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 represent the company in professional associations, conferences, and publications.
- Mentor and oversee less experienced statisticians and work with them to ensure other programs are properly supported, with the potential to manage full-time staff.
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.
Qualifications
- PhD in Statistics/Biostatistics with over 8 years of pharmaceutical industry experience (or MS in Statistics/Biostatistics with over 13 years). A PhD is strongly preferred.
- Preferred experience in rare disease, neurodegenerative disease, or gene therapy.
- 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.
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Additional Information
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides 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. For additional information about Regeneron benefits in the US, please visit For other countries’ specific benefits, please speak to your recruiter.
Please be advised that Regeneron requires roles to be performed on-site in many instances. Speak with your recruiter and hiring manager for information about on-site policy and expectations for your role and location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Salary Range (annually): $205,000.00 - $341,600.00
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