Massachusetts Licensed Executive Director Biostatistics

Job Summary

Collaborating with clinical development teams, the remote Senior/Executive Director Biostatistics will provide statistical expertise for clinical study designs, oversee outsourced biostatistical activities, and ensure high-quality deliverables while contributing to regulatory submissions and publications.

Key responsibilities:

• Design clinical trials with appropriate statistical principles and support global Health Authority interactions as the Biostatistics representative
• Collaborate with data management and clinical operations to align statistical analysis plans with data collection procedures
• Provide statistical input for clinical protocols and oversee the review of outsourced statistical deliverables

Required qualifications:

• Master's degree in Statistics/Biostatistics with 5+ years of relevant experience
• Strong R programming skills; SAS experience preferred
• Experience in oncology therapeutic area and prior support for BLA or NDA filings
• Understanding of clinical statistics and experience with CDISC standards
• Familiarity with clinical database software, especially Medidata RAVE