Your challenge

• Collaborate with clinical project team to establish project objectives and timelines for IVD/MD trials
• Providing statistical expertise to support study design, protocol development and 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 well as 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

Excellent spoken and written Englisch

Expected travel time <10% (location-dependent)

Our offer

We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 58.200,00 (minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.

If you have any questions or require further information about this job advertisement, please contact Manuela Silbermayr +43 664 8892 0539.

If you are passionate about promoting innovative medical devices and possess the skills and experience outlined above, we encourage you to apply for this exciting opportunity to join our dynamic team at GBO. Please submit your resume and cover letter detailing your relevant experience and qualifications. We look forward to hearing from you!