Executive Director, Biostatistics

The Executive Director, Biostatistics (CDU–Biostatistics Head, Internal Medicine) leads the statistical team for the assigned Clinical Development Unit, in partnership with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs, Development Operations and Development Program Management, R&D, and other key functions at Regeneron. The incumbent is an experienced leader, passionate drug developer, skilled manager and mentor, and an accomplished statistician with a strong ability to communicate technical concepts to non–statisticians.

The Executive Director is responsible for providing critical strategic input to the development programs within the CDU, from pre–IPA through regulatory approval and post–marketing, and builds and empowers teams to ensure the successful execution on our pipeline. The Executive Director drives the development of appropriate phase–specific statistical strategies that are developed and implemented, such as disease progression models at the CDU/disease/indication level to accelerate pre–clinical and early phase programs, adaptive and Bayesian designs for mid–phase programs, and rigorously controlled registrational studies for late–phase programs. The Executive Director ensures every development program has a well–developed quantitative and statistical strategy that leads to the successful development of medicines within that CDU. The Executive Director is also a leader within the Biostatistics and Data Management (BDM) organization and assists/leads in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure. This role is also responsible for project staffing and for appropriate resource allocation consistent with corporate priorities.

In this role, a typical day might include:

Drive the integration of quantitative thinking in the creation of clinical development plans (CDP) and study designs. Ensures statistical designs, data collection and analysis methodologies, and processes clearly and robustly address the objectives of clinical studies and programs.Partners with Statistical Programming and Data Management to ensure all aspects of statistical reporting are accurate and compliant with generally expected regulatory requirements. Lead development and optimization of statistical processes focusing on efficiency and quality, while maintaining or exceeding industry best practices.Oversees multiple therapeutic area and/or indication leads, and possibly compound leads within their CDU, ensuring leaders within the CDU provide appropriate strategic input to teams; oversees decision making of the Biostatistics TA/indication/compound leads for critical development milestones.Identifies the need, and develops/executes the plans, for strategies that impact the entire CDU, including but not limited to developing more efficient and powerful study designs, decision–making frameworks, disease progression models that integrate information from multiple sources, etc., in partnership with the Statistical Innovation Group, Biostatistical Engineering, Biostatistical Scientific Insights group, Statistical Programming, Clinical Imaging, Medical Affairs, HEOR (RWD), Precision Medicine, and other groups within Regeneron.Responsible for organizational design and structure, developing resourcing strategies for their area, establishing hiring standards, recruiting top talent, developing staff, supervising team performance, and proactively addressing gaps/issues to ensure performance goals/expectations are met. Manages external resources, establishing new partnerships with external resource providers as needed, to augment internal resources. Coordinates externalized resources across other BDM functions.Plans and tracks project activities, timelines, and resource use: Provide justification for planned resource needs and seek to optimize resource utilization across projects or areas. Works with senior management to ensure statistical representation in key project decisions and regulatory meetings and serve as departmental representative on corporate–wide teams.Actively represents Biostatistics at DPR and PRC. Ensures communication and alignment within BDM on issues before DPR/PRC within their area of responsibility. Mentors teams to improve their effectiveness in committee and senior management meetings. Provides input and oversight of TA/indication/compound leads in their leadership of key deliverables (e.g., clinical development plans, study protocols, Statistical Analysis Plans (SAPs), results dissemination communications, Clinical Study Reports (CSRs), and regulatory submission documents).Develops standards and policies tailored to the CDU that are harmonized with departmental guidelines/SOPs and industry standards, as well as developing policies promoting application of Regeneron Way in work practices. Shares best practices with the other leaders in Biostatistics.Contributes/leads to company–wide initiatives and cross–functional operational excellence initiatives.Presents, participates, and organizes at statistical and medical conferences; sponsors internal staff to be active at external professional meetings; and proactively seeks ways to represent the company externally. Actively participates in meetings with KOLs for the CDU.Influences regulatory agencies, in both product–related forums or more generally in the industry, and works with the company to develop a regulatory strategy to address statistical needs.Partners with Medical Affairs Biostatistics team to ensure alignment of statistical strategies and plans across Development/Medical Affairs.Partners with Biostatistics leadership to ensure the smooth functioning of the department.Other duties as assigned.This role might be for you if you have:Extensive knowledge of research and development and thorough understanding of the tasks required in all stages of drug development.A strong understanding of the people, processes and infrastructure involved in managing across the drug development lifecycle.Comprehensive knowledge of clinical development strategy and the role of quantitative and statistical contributions to drug development.Excellent written and verbal communication skills; strong communicator and influencer within all levels of the organization, including executive leadership. Knows what information and discussions are needed to help drive decisions and solve issues. Demonstrated ability to communicate technical statistical concepts to non–statisticians. Ability to distill complex issues and ideas down to simple comprehensible terms.Exceptional analytical capabilities, including quantitative and qualitative assessment skills, demonstrated critical thinking skills and strategic agility.Shows an innate curiosity to learn all aspects of the science behind the pipeline and to understand medical concepts and relevant biology for the diseases within the assigned therapeutic areas.Exceptional ability to lead people, identify and develop talent, and delegate effectively.Ability to prioritize multiple tasks and options with a strong attention to detail.Strong conflict resolution and problem–solving skills.Strong leadership and team building skills.Strong ability to influence without authority and work effectively in a matrixed and cross–functional environment.Demonstrated ability in statistical research activities and in the application of novel methods to clinical trial development.To be considered for this opportunity, you must have the following:12+ years of drug development experience, with experience in all phases of drug development from pre–clinical research through regulatory approval, including 5+ years' experience in the assigned CDU.Prior supervisory and project management experiences are required.PhD in Statistics, Biostatistics or related area.

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