CMC Statistics Director: Global Analytics & Compliance Leader

Scorpion Therapeutics; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a CMC Statistics Director (Scientific Fellow) to provide strategic and technical leadership across the product lifecycle, including process development, analytical development, manufacturing, and regulatory submissions.

You will establish a CMC Statistics Center of Excellence and partner with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to drive adoption of statistical best practices, DOE, and data analytics.

Qualifications

• Ph.D. or M.S. with extensive pharma statistics experience.
• Demonstrated CMC development/process validation/manufacturing/regulatory submissions experience.
• Preferred: biologics/cell & gene therapy experience.
• Experience establishing statistical governance and capability-building in regulated environments.

Responsibilities

• Provide strategic statistical leadership across the CMC lifecycle.
• Establish and lead a CMC Statistics Center of Excellence.
• Lead statistical work for characterization, optimization, robustness studies, technology transfer, and lifecycle management.
• Apply DOE for development, optimization, and control strategy development.
• Implement statistical approaches for PPQ, CPV, SPC, and process capability monitoring.
• Support analytical method development/validation/lifecycle management with sound study design.
• Serve as SME for exploratory data analysis, regression, multivariate, and predictive modeling.
• Drive adoption of advanced analytics, ML/AI-enabled statistical approaches.
• Author/review/defend statistical content for regulatory submissions.

Skills

Leadership

Communication

DOE expertise

Multivariate analysis

Process validation

Statistical leadership

Regulatory submissions

Data analytics

Machine learning

Project management

Education

Ph.D.

M.S.

Tools

JMP

Minitab

SAS

R

Python

Job description

Scorpion Therapeutics seeks a CMC Statistics Director (Scientific Fellow) to provide strategic and technical leadership across the product lifecycle, including process development, analytical development, manufacturing, and regulatory submissions.

You will establish a CMC Statistics Center of Excellence and partner with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to drive adoption of statistical best practices, DOE, and data analytics.