California Licensed Director of Statistical Science

Job Summary

A company is looking for an Associate Director/Director of Statistical Science.

Key Responsibilities

• Oversee biostatistics activities for clinical trials, ensuring timely and accurate statistical designs and analyses
• Consult on clinical trial design, review protocols, and prepare statistical methods sections
• Develop statistical analysis plans and manage statistical deliverables while coordinating with cross-functional teams

Required Qualifications

• PhD or MS in Statistics/Biostatistics with a minimum of 5 years of relevant industry experience; PhD preferred
• Strong knowledge of FDA guidelines, ICH guidelines, and CDISC standards
• Experience with oncology clinical trials and BLA/NDA submissions is strongly preferred
• Comprehensive knowledge of statistical methodologies, including Bayesian modeling and adaptive design
• Proficiency in SAS and/or R programming