Senior Director, Biostatistics - Immunology & Inflammation

Scorpion Therapeutics; New Jersey; On-site; USD 250,000 - 400,000; Full time

Job summary

Scorpion Therapeutics seeks a senior Biostatistics leader to guide statistics and data management across clinical development. You will drive study design, analyses, and regulatory strategy, collaborating with all departments to ensure robust data submission packages.

The role requires deep expertise in clinical trial statistics, regulatory expectations, and team leadership, with a track record of influencing senior stakeholders and leading large-scale initiatives.

Qualifications

• PhD in statistics with 10+ years in biotech/pharma/health.
• MS in statistics with 15+ years in biotech/pharma/health.

Responsibilities

• Determine Department goals and allocate resources with the Department Executive Director.
• Ensure project teams have high-quality statistical support for clinical development plans, study design, and operations.
• Provide statistical representation in key project decisions and regulatory meetings; serve as departmental representative on corporate teams.
• Oversee statistical reporting; review SAP, analysis results presentations, CSR, integrated summaries; ensure compliance with submission guidelines.
• Plan and track project activities, timelines, and resource use; justify resource needs; optimize resources; 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; develop policies aligned with corporate values.

Skills

Leadership

Project management

Communication

Teamwork

Regulatory knowledge

Education

Ph.D. in statistics

MS in statistics

Tools

SAP

Job description

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.

This Role Requires

• - 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.

When & Where

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