Senior Biostatistician (Analytical Validation)

Master’s degree in biostatistics, statistics, or equivalent with 3+ years of relevant experience; or PhD in Biostatistics, Statistics, or equivalent with 1+ years of relevant experience

Minimum of 2 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP

Experience designing and executing statistical analyses in a regulated environment a plus

Expert applied knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI guidelines

Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds

With minimal guidance, drive the design and execution of analyses for analytical validation studies in support of CLIA LDT and

in vitro

diagnostic (e.g., IVDR, 510(k), PMA, etc.).

Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for studies of varying complexity

With minimal guidance, produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation

Effectively convey statistical concepts and results to cross-functional collaborators and stakeholders