Provide statistical support for product development, analytical and clinical validation studies to achieve registration, clearances and premarket approval of IVD and companion diagnostic assays in the US and internationally.
Design statistical aspects of studies, write statistical analysis plans, analyze data and write statistical reports with general supervision.
Collaborate with cross-functional teams on study designs, strategies, and analysis approaches consistent with best statistical practices and regulatory requirements.
Provide statistical designs for clinical or analytical studies based on regulatory guidance or CLSI (Clinical and Laboratory Standards Institute) standards.
Write, review and edit statistical analysis plans and study reports.
Utilize appropriate statistical tools and techniques to analyze data and summarize data analysis results orally and in written form.
Support responses to statistical queries from registration bodies.
Consult with any functional group within the company on the appropriate use of statistical methods.
Create all relevant documentation pertaining to statistical design and analysis at a level consistent with auditable standards in the IVD industry.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Master's degree in Biostatistics, Statistics or related field preferred.
Minimum of 5 years of related work experience with a Bachelor's degree; or 3 years and a Master's degree, or a PhD without experience.
Proficiency in at least one statistical analysis software package (e.g. SAS, JMP scripting, R).
Good verbal and written communication skills for both technical and non-technical audiences.
Able to prioritize work and complete deliverables to timelines with general supervision.
Experienced in and full understanding of at least one area of statistics: clinical or analytical studies for in vitro diagnostics (IVDs); companion diagnostics; ROC analysis; basic linear models including analysis of variance and regression analysis; sample size estimation; Design of Experiments (DOE), statistical quality control; clinical trials; observational studies; missing data imputation; survival analysis; statistical genetics; computational statistics; propensity scores; device, drug or biologics registration studies.
Able to interpret and apply CLSI and other related regulatory guidance/standards.
Able to travel domestically or internationally, as required up to 10%.
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