Clinical SAS Programmer
Clinical SAS Programmer
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1 Vacancy
Job Description
- Review protocols for CDISC conformance.
- Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements.
- Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes SDTM Implementation Guide project standards and the study protocol.
- Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets.
- Review and QC submission ready SDTM datasets and supporting documentation as appropriate.
- Provide CDISC training and serve as subject matter support to project staff.
- Maintain and coordinate CDISC standards efforts ensure maximum reuse of applied standards involvement in ongoing process improvement efforts and working with teams to provide technical and process guidance.
- Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation.
- Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations.
- Good understanding of the statistical programming domain and related processes.
- Assists with developing monitoring and enforcing productivity and quality standards along with related documentation.
- Coordinating with the project management in meeting the timeline and defining/ capturing the metrics for monitoring and maintaining the quality and productivity.
- Bachelors or masters degree in computer science Management Information Systems or a related field.
- Minimum of 5 years of experience in using SAS to process and analyze large datasets.
- Experience in conducting data quality reviews including clinical data tables graphs and reports.
- Experience in developing technical documentation.
- SAS Certified Base Programmer certification required.
- Experience with development documentation and testing of analysis data and programming code to meet regulatory and company standards.
- Good organizational and communication skills the ability to work in a collaborative environment and a desire to improve skills are essential.
- To perform this job successfully an individual must be able to perform each essential duty satisfactorily.
Employment Type
Full-time
