Katalyst CRO ยท 2 months ago
Clinical SAS Programmer
Raleigh, NC
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a company focused on clinical research services, and they are seeking a Clinical SAS Programmer to support their clinical data management efforts. The role involves writing and managing SAS code, ensuring compliance with CDISC standards, and providing training and support to project staff.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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 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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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