Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – firstname.lastname@example.org
Confirmed tasks: Full end to end Programming in SAS, producing SDTM specs and aCRF, taking raw data and converting to SDTM datasets, Validate, P21 Enterprise updates, transfer to biostats. Support MW with coding reconciliation reports. INFORM
Job Summary (Primary function):
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).
Essential Functions of the Job (Key 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.
Qualifications (Minimal acceptable level of education, work experience, and competency):
• 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.