Statistical Analyst Medical Devices/IVDs

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Job Reference:

4b68185e2ba6

Job Views:

3

Posted:

19.06.2025

Expiry Date:

03.08.2025

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Job Description:

• Collaborate with clinical project team to establish project objectives and timelines for IVD/MD trials
• Providing statistical expertise to support study design, protocol developmentand data interpretation
• Writing of statistical analysis plans, statistical sections of trial protocols and synopses as well as contributions to other regulatory documents
• Prepare datasets and perform data analysis as well as programming of tables, listings and figures
• Close cooperation with data management during creation of data collection forms
• Performs quality check of datasets in cooperation with data management and identify outstanding data errors
• Work with clinical study teams to ensure the up-to-date and error free data are available at the time of analysis
• Create, document and maintain detailed data definition and inventory of all data and program
• Provide statistical analysis support of scientific publication/presentations as wellas customer related information
• Maintain/Update and validate statistical program
• Maintain/Update of statistical SOPs, forms and other relevant study or process documents
• Prepare and communicate statistical concepts within GBO and external

Your profile

• PhD in Statistics, Biostatistics or related field within 3+ years industry experience
• MS in Statistics, Biostatistics or related field within 5+ years of industry experience
• Knowledge of statistical methods within clinical laboratorians are a must
• Experience in MD/IVD trials are beneficial
• Ability to work independently in project management and decision making
• Able to effectively communicate the own ideas
• Ability to use R or equivalent statistical software
• Good knowledge of current industry practices related to the conduct of clinical studies (ICH-GCP, ISO 14155, ISO 20916)
• Good knowledge of FDA requirements to IVDs and MDs, ISO regulations and CLSI guidelines