• Lead Biostatistics efforts designing and executing analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.). • Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for validation studies of varying complexity. • Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation. • Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders. • Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams. • Mentor and provide technical supervision to junior team members. • Perform other duties as assigned.