Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- 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, define.xml, 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.
Requirements:
- Bachelor's or master's 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.