Summary

The Clinical Database Programmer produces standard and custom reports for use by the Clinical Data Managers in their data review and cleaning efforts, develops transfer specifications with vendors for external data sources, and performs Study Data Tabulation Model (SDTM) conversion programming and Quality Control (QC). 

Duties and Responsibilities

• Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS.
• Program reports and listings as requested by project team members for ongoing studies.
• Develop transfer specifications with vendors for external data sources.
• Perform consistency checks on data transferred between Incyte and external parties to ensure completeness and accuracy of data contained transfers.
• Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format.
• Perform Quality Control (QC) on programming work performed by fellow Database Programmers.
• Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency

Requirements

• Bachelor’s degree OR certification.
• Minimum of 5 years of clinical SAS programming experience in the pharmaceutical industry.
• Working knowledge of CDISC SDTM mapping/specs/conversion/domains/datasets/eCRF/eCRT Package/define.xml development and SDTM data transfer operations on clinical studies.
• Understanding of regulatory requirements relevant to submissions.
• Knowledge of clinical trial study design and electronic data submission requirements.
• Communication and interpersonal skills and the ability to work effectively as part of a team.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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