Associate Director, Biometrics

ASSOCIATE DIRECTOR, BIOMETRICS Responsibilities

• Provide statistical leadership and independent guidance for assigned clinical development programs/projects, including study design, analysis, interpretation, and development strategy.
• Serve as the statistical lead on cross-functional study and project teams; recommend solutions to complex statistical issues.
• Lead statistical strategy and execution across assigned studies to ensure scientific rigor, consistency, and alignment with regulatory and industry standards.
• Design clinical trials and provide statistical guidance.
  • Provide sample size estimates.
  • Write statistical sections of study protocols, statistical analysis plans (SAPs), and study reports.
  • Develop clinical trial randomization.
  • Review study protocols, CRFs, database structures, study reports, and annual reports.
  • Lead review and discussion of SAP.
• Oversee CRO statistical activities and deliverables (quality, timelines, and SAP implementation).
• Maintain study documentation of statistical analyses and supportive documents.

• PhD in Statistics/Biostatistics (or related) with at least 5 years relevant experience, or Master’s with at least 8 years relevant experience.
• Proficient with SAS and other statistical software (e.g., R).
• Proven knowledge of CDISC standards and application to projects.
• Advanced oral and written communication skills.

Carlsbad, CA (onsite preferred); remote may be considered; relocation assistance available for eligible candidates.