Senior Director, Biostatistics - Multi-modal Endpoint / Disease Progression

Senior Director, Biostatistics - Multi-modal Endpoint / Disease Progression

In this role, a typical day might include:

The Senior Director, Biostatistics leads a matrixed team of statisticians and other quantitative scientists within the Biostatistics organization, partnering with the Clinical Development Unit-focused statisticians, Biostatistical Engineering, Scientific Insights and Medical Affairs groups within Biostatistics, as well as leadership within Statistical Programming and Data Management, Clinical Sciences, Imaging, Precision Medicine, Digital Medicine, R&pD, and other key scientific 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 Senior Director is responsible for providing critical input to novel quantitative strategies that improve decision making for clinical-stage compounds, including but not limited to leveraging multiple measurement modalities (e.g. Imaging, biomarkers) in decision making, developing novel endpoints to quantify drug effects, and modeling disease progression to understand when and how to treat patients.   The incumbent is accountable for conceptualizing and executing on quantitative approaches to solve these drug development problems.  The Senior 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.

This role might be for you if have proven experience:

• Drives the integration of quantitative thinking in the creation of clinical development plans (CDP) and study designs.  Ensures statistical input to endpoint collection and development clearly and robustly addresses clinical study and program objectives.

• Identifies the need, and develops/executes the plans, for strategies that impact the Regeneron pipeline, 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.

• Develops standards and policies harmonized with departmental guidelines / SOPs and with industry standards, as well as developing polices 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 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 work with company to develop a regulatory strategy to address statistical needs.

• Partners with Biostatistics leadership to ensure the smooth functioning of the department. 

• Other duties as assigned

To be considered for this opportunity, you must have the following:

• Ph.D. in statistics or related discipline with 12+ years of experience (or MS in statistics or related discipline with 15+ years) in the biotechnology, pharmaceutical or health related industry, including significant interaction with both