Contd from H.8 In lieu of a Masters degree and 2 years of experience, employer will accept a PhD degree or equivalent in Statistics, Biostatistics or a related field.br br Contd from H.10B to include any relevant job titles within this occupation.br br Contd from H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. SAS programming. 2. Utilizing R or SPlus software packages. 3. Applying theoretical and applied statistics to perform statistical testing, generate outputs, and validate the tables, listings, and figures for Premarket Application. 4. Working with regulatory guidelines GP and FDA as they apply to a pharmaceutical or medical device research setting. 5. Developing Statistical Analysis Plans SAP and supporting the statistical execution effort for clinical studies. 6. Developing statistical programs to ensure the accuracy of the planned and completed analyses or exploratory analyses. 7. Reviewing protocols, contributing to protocol statistical analysis sections, and generating study randomization schema. 8. Authoring results sections of the Clinical Study Reports CSR and supplying statistical input for premarket approval submissions and in response to regulatory questions. 9. Providing independent validation of the statistical content in study documents including randomization, study reports, briefing documents, patient brochures, and publications delivered to external entities. 10. Keeping abreast of new developments in statistics, device development, and regulatory guidance. 11. Developing case report forms and clinical database and performing data cleaning to ensure quality data selection. The employer will accept academic background with the listed skills from the applicants with PhD degree.br Hiring Requirements Drug TestingScreening, Background Checks.
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