Regeneron Pharmaceuticals-posted 9 months ago
$238,400 - $397,300/Yr
Full-time • Senior
Tarrytown, NY
Professional, Scientific, and Technical Services

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&D, 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.

  • 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.
  • Responsible for organizational design and structure, developing resourcing strategies for their area.
  • Establishes hiring standards, recruits top talent, develops staff, supervises team performance, and proactively addresses gaps/issues.
  • Manages external resources, establishing new partnerships with external resource providers as needed.
  • Coordinates externalized resources across other BDM functions.
  • Plans and tracks project activities, timelines, and resource use.
  • Works with senior management to ensure statistical representation in key project decisions and regulatory meetings.
  • Develops standards and policies harmonized with departmental guidelines / SOPs and with industry standards.
  • 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.
  • Actively participates in meetings with KOLs for the CDU.
  • Influences regulatory agencies and works with the company to develop a regulatory strategy.
  • Partners with Biostatistics leadership to ensure the smooth functioning of the department.
  • 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.
  • Significant interaction with both FDA and EMEA.
  • History of successful project and people management (6+ years).
  • Expertise in multiple therapeutic areas.
  • Extensive knowledge of research and development and thorough understanding of the tasks required in all stages of drug development.
  • Comprehensive knowledge of clinical development strategy and the role of quantitative and statistical contributions to drug development.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to communicate technical statistical concepts to non-statisticians.
  • Exceptional analytical capabilities, including quantitative and qualitative assessment skills.
  • Strong conflict resolution and problem-solving skills.
  • Strong leadership and team building skills.
  • Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
  • Ability to distill complex issues and ideas down to simple comprehensible terms.
  • Shows an innate curiosity to learn all aspects of the science behind the pipeline.
  • Health and wellness programs
  • Fitness centers
  • Equity awards
  • Annual bonuses
  • Paid time off for eligible employees
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