US, US, CA - San Diego
Minimum Level of Education Required: Masters Degree
Percentage of Travel: Up to 25%
Location: CA - San Diego
Our Lead Biostatistician is key in supporting all areas of clinical database management and biostatistical output for NuVasive, a service provider of intraoperative neuromonitoring and manufacturer of spinal and specialized orthopaedic devices. The Lead Biostatistician will contribute to protocol and post-market clinical follow up (PMCF) plan generation, data collection, data quality initiatives, database management, data reporting, data analysis, results interpretation, and reporting in all relevant internal and external venues.
· Responsible for study design, sample size justifications, and statistical analysis planning for post-market studies and plans.
· Oversee database management team and develop standard operating procedures (SOPs) regarding data management and quality processes.
· Organize and process historical data sources, in collaboration with organizational priorities and clinical scientists/medical writers.
· Strategize and fulfill predictive analytic programs from clinical and business datasets.
· Oversee data collection and reporting on multicenter patient outcomes registry.
· Develop and implement organizational SOPs for statistical guidelines in protocol and data collection planning and execution.
· Achieve statistical excellence, producing clear, accurate, and creatively produced and written work for a variety of audiences.
· Demonstrate a high level of product and procedure knowledge to support research-related questions and independently provide internal/external training on statistics as necessary.
· Provide training, mentorship, and guidance for junior team members in all aspects of biostatistics and database management.
· Develop and implement corporate procedures for medical writing.
· Assist research and other project team members in additional responsibilities as required.