Associate Director Of Biostatistics

Associate Director of Biostatistics Overview

• Lead biostatistics operations, ensuring efficient project management and adherence to regulatory guidelines.
• Provide oversight for statistical analysis and programming, contributing to clinical trial success.
• Mentor and develop biostatistics staff, fostering professional growth and succession planning.
• Collaborate with clients to manage projects and strengthen relationships effectively.
• Establish and maintain Standard Operating Procedures to ensure consistency and efficiency.
• Support business development through proposal contributions and sponsor bid defense meetings.
• Ensure deliverables meet expectations and align with study document analysis.
• Maintain knowledge of clinical drug development processes and regulatory guidelines.
• Contribute to training plans and materials to enhance team capabilities.

Associate Director of Biostatistics Key Responsibilities & Duties

• Manage staff performance, training needs, and professional development initiatives.
• Assign biostatisticians to projects based on skills and experience, ensuring utilization goals.
• Prioritize activities across projects, resolving conflicts to maintain departmental effectiveness.
• Develop staff skills to meet diverse business needs and support succession planning.
• Set achievable goals for associates, providing timely feedback and performance appraisals.
• Assist in solving technical problems with cost-effective resolutions.
• Contribute to business development activities, including proposals and sponsor meetings.
• Conduct senior reviews of project deliverables to ensure quality and consistency.
• Train new hires and enhance existing personnel skills through structured programs.

Associate Director of Biostatistics Job Requirements

• Master's or PhD in Biostatistics or related field required.
• Minimum 7 years of experience in clinical trials; 15 years preferred.
• Extensive knowledge of FDA and ICH guidelines and drug development processes.
• Proven leadership ability and management experience in biostatistics.
• Strong written and verbal communication skills in English.
• Ability to apply statistical design, analysis, and programming techniques effectively.
• Experience with regulatory submissions is highly preferred.
• Capability to mentor and train biostatistics staff for skill enhancement.
• Willingness to travel up to 25% as required.