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Biostatistiscian

Our Corporation is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well-being of people around the globe with well-known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care (POC). Our core competencies and capabilities focus on immunoassay and molecular testing in the areas of: infectious disease, women’s health, and virology.

We are searching for a subject matter expert in statistics to help achieve our vision of outcome driven diagnostics. The selected statistician will interact cross functionally with various departments such as R&D, Clinical/Regulatory, Quality, Engineering, and Operations presenting statistical expertise on product development projects and other matters. This role will report directly to the Senior Vice President of R&D.

Job Responsibilities:

– Develops statistical approaches for optimal experimental design, devises sampling techniques, makes sample size determinations to support product development, clinical trials, and regulatory activities

– Supports development of experimental protocols, writes reports, networks with key decision makers internally and represents company in professional settings externally.

– Determines the statistical validity of R&D reports supporting product development

– Provides biostatistical support to product development (IVD assays, instruments, and software) and product evaluation (design verification & validation).

– Establishes maintains and continuously improves the use of uniform, companywide harmonized data reduction procedures and tools for the generation & presentation of product performance data.

– Provides quantitative epidemiological data analyses linking disease incidence and prevalence with instrumentation that transmits data wirelessly to public health and other interested parties.

– Provides statistical training to research and clinical associates, engineers, scientists, and other non statistical professionals.

– Writes requirements and reviews statistical documentation in support of clinical trials and regulatory submissions

Requirements:            

Education and Experience:

– MS in Biostatistics is a must; PhD is preferred.

– Minimum of eight years of experience in relevant industry experience with demonstrated progressively increasing responsibilities

Knowledge/Skills:

– Practical experience in R&D and in-vitro diagnostics industry or related areas.

– Familiarity with R and SAS applications and DoE software packages

– Expert knowledge in experimental design (DoE)

– Expertise in standard statistical techniques (e.g. experimental designs, statistical modeling, exploratory data analysis, sample size determinations, statistical simulation)

– Demonstrated ability to define and propose new methods and procedures for obtaining results.

– Knowledge in: mathematical statistics, non parametric statistics, applied probability, multivariate analysis, nonlinear regression, generalized linear models, categorical data analysis, and statistical quality control.

– Working knowledge of algorithms, optimization, simulation and survey sampling.

– Demonstrates ability to collaborate effectively and work in a matrix organization.

– Service orientation towards internal customers

– High degree of self-motivation and commitment

– Strong communication skills, written and verbal.

– Some exposure to modern data analysis techniques such as visualization

– Demonstrates ability to consistently meet proposed objective timelines, applying competent use of project planning and project management skills.

– Knowledge of related quality system regulations and processes.

Job ID: 1486

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