Responsibilities

• Perform in a lead Biostatistician role providing technical expertise for high complexity clinical studies
• Provide expert level statistical guidance for innovative study design and clinical development plans
• Develop statistical sections of study protocols for clinical studies
• Interpret analysis results and ensure reporting accuracy in study reports and regulatory documents
• Conduct overall statistical review of TFLs for clinical studies
• Manage operations with internal statistical programmers to ensure quality of deliverables
• Represent Biostatistics in interactions with regulatory authorities like the FDA
• Support the preparation of abstracts, manuscripts, and written reports
• Create, maintain, and implement SOPs and processes to ensure compliance and efficiency

Requirements

• Master's degree or higher in Statistics, Biostatistics, or Math
• 10+ years...