Biostatistician Iii
Current• Efficiently and effectively coordinate statistical reporting activities for multiple projects across multiple development phases.• Develops and reviews statistical analysis plans based on study-specific documents and sound statistical methodology.• Ensure the efficiency, quality, and integrity of analyses, data reporting, and project activities executed.• Develops, maintains, and produces statistical programs and specifications used in creating analysis datasets (ADaM), and statistical displays• Applies knowledge of basic and complex statistical design, analysis, and programming techniques utilized in clinical research.• Works with internal project teams to identify project priorities and communicate such activities and associated timelines to department management.• Possesses knowledge of the common elements of the drug development process and applicable FDA and ICH guidelines.• Effectively communicate oral and written statistical concepts and results with both statisticians and non-statisticians.• Maintains awareness of project budgets and tasks, and effectively communicates the status of such tasks to administrative and project management.• Communicates accurate and timely project updates to other team members, colleagues, and senior management.
