CMC Quantitative Sciences Director — Data-Driven Drug Development

Neurocrine Biosciences; San Diego (CA); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Annual bonus target: 35%

Equity-based long-term incentive program

Retirement savings plan with company match

Health benefits including medical and dental

Job summary

Neurocrine Biosciences is seeking a Scientific Director for CMC Quantitative Sciences in San Diego, CA. This senior role involves designing data-driven strategies and being the statistical authority for drug product development programs. Collaborating with various departments ensures that all decisions rely on rigorous statistical analysis.

The ideal candidate will possess a PhD or equivalent and have substantial experience in statistical methods within pharmaceutical development. This role emphasizes integration across functions, influencing teams, and ensuring regulatory compliance.

Qualifications

• 12-15+ years of experience in statistical analysis in pharmaceutical development.
• Hands-on experience with late-stage development and regulatory submissions.
• Demonstrated expertise in multivariate analysis and process variability.

Responsibilities

• Designs and advances data-driven development initiatives.
• Provides statistical guidance for regulatory submissions.
• Supports troubleshooting efforts on formulation and process development.

Skills

Statistical analysis

Design of Experiments (DoE)

Statistical modeling

Cross-functional team influence

Education

PhD, PharmD, or MS in Statistics or related field

Tools

JMP

R

Python

Job description

Neurocrine Biosciences is seeking a Scientific Director for CMC Quantitative Sciences in San Diego, CA. This senior role involves designing data-driven strategies and being the statistical authority for drug product development programs. Collaborating with various departments ensures that all decisions rely on rigorous statistical analysis.

The ideal candidate will possess a PhD or equivalent and have substantial experience in statistical methods within pharmaceutical development. This role emphasizes integration across functions, influencing teams, and ensuring regulatory compliance.