Regeneron Hiring Associate Director of Biostatistics for Thrombosis in Warren, NJ

Regeneron Pharmaceuticals, Inc. Is expanding its Global Development team with the addition of an Associate Director, Biostatistics – Thrombosis based in Warren, New Jersey. This pivotal role is designed for a qualified statistician or biostatistician capable of bridging the gap between complex data analysis and strategic drug development.

The Role of Associate Director, Biostatistics

The Associate Director serves as a critical link within the Biostatistics department, working alongside cross-functional teams to advance drug development. The primary focus of this position is to articulate essential drug development questions, evaluate the feasibility of endpoints and establish the statistical frameworks necessary to answer those questions. From designing clinical experiments to overseeing interventional studies, the incumbent ensures that data is generated and analyzed with precision to drive informed decision-making.

Key Responsibilities and Expectations

The daily operations of this role are diverse, blending technical expertise with organizational leadership. Core duties include:

• Clinical Trial Design: Designing clinical experiments and interventional studies to generate robust data for analysis.
• Cross-Functional Collaboration: Interacting with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze trials.
• Regulatory Representation: Representing statistical issues during regulatory agency meetings and preparing essential materials, including analysis plans, Tables, Listings, and Figures (TFLs), and slides for advisory committee meetings.
• Infrastructure Development: Leading the creation of new infrastructure, processes, and authoring new or revised Standard Operating Procedures (SOPs).
• External Engagement: Representing Regeneron in professional associations, publications, and conferences.

Leadership and Mentorship

Beyond technical contributions, the Associate Director carries significant leadership weight. The role involves mentoring and overseeing less experienced statisticians and includes the potential to manage full-time staff. The incumbent leads the development and delivery of training programs for non-statistical colleagues to ensure company-wide alignment on data interpretation.

Candidate Qualifications

To be successful in this role, candidates must possess a strong foundation in statistical science and a proven ability to lead technical workstreams. According to job requirements, the position requires:

• Education: A Master’s Degree or MBA.
• Expertise: Proven experience as a qualified statistician/biostatistician within a clinical or global development setting.
• Competencies: Ability to lead contributions to regulatory interactions and contribute to cross-functional EPIC workstreams.

Frequently Asked Questions

What is the primary goal of this position?

The primary goal is to lead Biostatistics efforts within cross-functional teams to design clinical experiments, analyze resulting data, and interpret results to guide drug development decisions.

Who does this role collaborate with?

The Associate Director interacts with a wide array of professionals, including Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, and Medical Writing.

Does this role involve people management?

Yes, the Associate Director is responsible for mentoring and overseeing less experienced statisticians and has the potential to manage full-time staff.

As Regeneron continues to push the boundaries of pharmaceutical innovation, this role offers a unique opportunity for a biostatistics expert to influence the trajectory of thrombosis treatments through rigorous scientific design and regulatory leadership.