Senior Director, Biostatistics - Immunology & Inflammation

Discover Your Role

• - Determine Department goals and resource allocation with the Department Executive Director.
• - Ensure project teams have high-quality statistical support for clinical development plans, study design, and operational aspects.
• - Provide statistical representation in key project decisions and regulatory meetings; serve as departmental representative on corporate-wise teams.
• - Oversee statistical reporting; review critical documents (SAP, analysis results presentations, CSR, integrated summaries) and ensure compliance with data submission guidelines.
• - Plan and track project activities, timelines, and resource use; justify resource needs; optimize resource utilization; conduct long-range planning.
• - Provide technical direction and mentoring; recruit, develop, and retain high-quality staff.
• - Maintain awareness of industry standards and regulatory requirements; harmonize policies/SOPs with standards and develop policies aligned with corporate values.

• - Ph.D. in statistics (10+ years) or MS in statistics (15+ years) in biotech/pharma/health industry; significant interaction with FDA and EMEA; 6+ years successful project and people management; expertise across multiple therapeutic areas.
• - Active research interests related to clinical trials.
• - Ability to exercise judgment in applying/modifying procedures and methods to specific problems.
• - Independent, self-directed, high-energy; creativity and attention to detail.
• - Strong leadership, project management, teamwork, and interpersonal skills; excellent presentation skills.
• - Experience leading major process/technology initiatives across functional groups.
• - Broad understanding of advanced statistical concepts/techniques.
• - Ability to represent Biostatistics and Data Management with senior leadership/cross-functional committees.
• - Thorough knowledge of pharmaceutical clinical development and lifecycle management; regulatory guidelines and statistical practice.
• - Understanding of drug discovery/development process globally.
• - Strong administrative skills and ability to influence others.

• - Work location:
  
  Tarrytown, NY;
  Cambridge, MA; or Warren, NJ. 4 days/week on site; up to 25% travel may be required.