Senior Director of Biostatistics

Job Summary

A company is looking for a Senior Director of Biostatistics.

Key Responsibilities:

• Lead the biometrics team and provide statistical input for clinical development programs
• Author statistical analysis plans and collaborate with cross-functional teams to ensure high-quality data
• Interact with global health authorities and manage CRO/vendor oversight for statistical deliverables

Required Qualifications:

• PhD in Biostatistics, Statistics, or a related field with 10-12 years of experience in biostatistics
• Strong knowledge of statistical methodologies used in clinical trials
• Experience with regulatory submissions and interactions with regulatory agencies
• Proficiency in statistical software (e.g., SAS, R) and data management systems
• Experience with CDSIC including SDTM, ADaM, CDASH