Clinical Data Associate
Jobot Blacksburg, VA
- Expired: over a month ago. Applications are no longer accepted.
This Jobot Job is hosted by: Emmet Nitto
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Salary: $65,000 - $90,000 per year
A bit about us:
Based in Blacksburg VA, we are a biotech startup developing an oral first-in-class therapeutics designed to target autoimmune diseases. We are looking for a Clinical Data Associate to join our growing team!
Why join us?
- Competitive Salary!
- Extremely Competitive Benefits Package
- Adaptable/Flexible Schedule!
Statistical programming: Program from scratch as well as update existing programs to perform data management, presentation and analysis. Create Study Data Tabulation Models (SDTM) and Analysis Data Models (ADAM) based on Clinical Data Interchange Standards Consortium (CDISC) for internal and FDA review of trial data. Develop, review, validate, and execute SAS programs to create tables, listings, and figures for company studies to support the demonstration of the safety and efficacy of company therapeutics as defined in the statistical analysis plan. Create and execute macros. Program database integrations.
Data accuracy and integrity: Program data cleaning/consistency checking programs to support internal applications for all therapeutic areas. Review data editing and export specifications. Document all programming and validation efforts in accordance with Good Clinical Practices. Create, execute and validate edit check programs. Maintain security of databases and restricted files.
Review and testing: Program and test data export programs. Perform test transfers to ensure efficient processing of data once received from vendors. Use SDTM guidelines to create and receive transfer datasets. Review and provide input on Statistical Analysis Plans, case report forms, data management plans, and TFL specifications. Participate in user testing of case report forms, databases and other inputs into clinical trial management.
Quality and standard operating procedures: Generate and maintain standard operating procedures (SOPs) for clinical data programming and research tasks. Ensure compliance to SOPs and standards in conduct of research. Participate in development of QC test plans, conventions, specification documents and processes. Maintain a library of reusable code.
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