New Jersey Licensed Biostatistics Director

Job Summary

Working remotely, the full-time salaried New Jersey Licensed Biostatistics Director will provide statistical and programming expertise for clinical study designs, data analysis, and regulatory submissions while collaborating with cross-functional teams and overseeing outsourced biostatistics activities.

Key responsibilities

• Collaborate with the clinical development team to design clinical trials and ensure appropriate application of statistical principles
• Support global Health Authority interactions as the Biostatistics representative and manage randomization plans
• Provide rigorous 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
• Prior experience in the oncology therapeutic area
• Experience supporting BLA or NDA filings and interacting with health authorities
• Knowledge of clinical database software, CDISC standards, and regulatory requirements (GCP, ICH, FDA)