Associate Director, Biostatistics

Job summary

The Associate Director of Biostatistics serves as a statistical expert in the clinical development of compounds, acting as the lead for designated compounds or indications. This role involves contributing to clinical development strategies and ensuring consistency in statistical methods across trials.

Qualifications

• Master's or PhD in a statistical discipline
• 8+ years of relevant experience, preferably in drug development for biologics and targeted therapies
• Familiarity with FDA, EMA, and ICH guidance on drug development statistics
• Experience with regulatory submissions and interactions with health authorities

Responsibilities

• Lead statistical efforts for designated compounds, ensuring effective communication and collaboration among biostatisticians and stakeholders
• Provide statistical input to clinical development teams and represent the company in regulatory meetings
• Oversee trial-level statistical work, ensuring compliance with company standards and regulatory requirements
• Coordinate data transfers and ensure quality control of statistical deliverables

Skills

• Proficient in statistical analysis, modeling, and simulation
• Strong understanding of adaptive trial designs and relevant regulatory requirements
• Excellent communication and networking skills

Education

• Master's or PhD in a statistical discipline

Tools

• Familiarity with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions