Company Name:-
BioClinica

Job Location:-
Remote

Job Summary:-
Provide statistical programming and clinical expertise in the production of SDTM and AdaM domains, tabulations, graphics, and listings from clinical trial data.

Prepare, document and test required programs and ensure programming code meet regulatory and company standards.

Primary Responsibilities
Provides data to clients (internal and external) in functional format by:
Creating and executing SAS edit check programs
Validating edit check programs using standard validation practices and processes
Developing SAS programs that convert data from Bioclinica EDC to protocol-specific SAS datasets in accordance with customer specifications
Assist with the creation of SAS-related project programming and validation documentation
Assist with the creation of SAS macro and format libraries
Ensures client data accuracy and integrity by
Reviewing and approving User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents
Developing and implementing new CDM systems and enhancements to current CDM systems
Understand, create and communicate information about creating CDISC-compliant datasets (SDTM and ADaM)
Create documentation related to the generation of customer specific SAS datasets
Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance
Assist the Study Quality Representative in the testing of protocol specific SAS conversion programs
Ensures project timelines are maintained by
Assessing and committing to target dates in conjunction with direct supervisor and project team
Adhering to target dates for project timelines
Communicating any changes in target date to appropriate personnel including Project Manager
Keeping department head informed of progress as well as potential impediments
Maintains Quality Service and Departmental Standards by
Adhering to established processes and standards
Reading, understanding and adhering to organizational Standard Operating Procedures (SOP)
Assisting in establishing and enforcing departmental standards
Participating in the modification of company SOPs
Secondary Responsibilities
Contributes to team effort by
Working with internal staff to resolve issues
Exploring new opportunities to add value to

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