Statistician

Posting Date 2 months ago(8/3/2020 1:28 PM)
Requisition ID
2020-7725
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Research Inc.
Category
Biomedical/Biotechnology

Overview

Cook Research Incorporated is currently accepting applications for a Statistician to become a part of our growing Biostatistics team.

Responsibilities

• Support the statistical needs of global projects on behalf of the organization

• Apply statistical and research methodological principles to the design, execution, analysis, and interpretation of clinical studies, as well as assist in defining the strategy for clinical studies

• Ensure that data and statistical activities comply with regulatory and company standards

• Author and provide input on relevant sections of clinical research protocols along with the content and format of data collection activities

• Advise on safety monitoring of clinical studies, including the development of appropriate study monitoring criteria

• Provide statistical support on the design and execution of bench and animal testing protocols and in the development of quality systems related to the manufacturing of medical devices

• Maintain familiarity with company statistical software and provide custom programming for data reporting and statistical analysis

 

Qualifications

• Master’s degree or PhD in Statistics

• Education and/or experience must include: using SAS programming language for import/export, transformation, statistical analysis and visualization of clinical data; experimental design; generalized linear regression; survival analysis; longitudinal data; mixed effect models; statistical/machine learning; statistical software tool (e.g. R, SPSS, and/or M-Plus); clinical studies; and FDA and other regulatory requirements

• Ability to program in the SAS language

• Prior experience in the conduct of clinical studies, preferably in the medical device industry

• Working knowledge of FDA and other regulatory requirements that may impact global clinical studies

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