Clinical SAS Programmer

Worcester, MA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 and supporting documentation as appropriate.
Provide CDISC training and serve as a 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 documentations.
Coordinating with the project management in meeting the timeline and defining/ capturing the metrics for monitoring and maintaining the quality and productivity.

Requirements:

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 analyse 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.

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...