Katalyst CRO · 3 months ago
Sr SAS Programmer
Irvine, CA
Full-time
Onsite
Senior Level
6+ years expKatalyst CRO is a company focused on clinical research, and they are seeking a Senior SAS Programmer to provide statistical programming and validation support for clinical study reports. The role involves overseeing programming activities by external vendors and ensuring timely and accurate programming and validation activities for clinical studies and publications.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following
To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies and publications
Contributes to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment area: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications)
Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files)
Working with external vendors to develop or monitor the content and structure of SAS data sets
Working closely with clinicians, statistician, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review
Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management
Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents
Maintaining standards for programming activities
Working independently to accomplish tasks and goals defined by supervisor
Qualification
Required
Minimum of bachelor's degree in related science discipline
Minimum 6+ years' experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office
Experience in CDISC data standards, e.g. SDTM and ADaM
Proven experience with Unix and Windows operating systems
Understanding of the software development life cycle
Understanding of FDA guidelines
Good organization, time management, and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality
Applies good judgment and demonstrates initiative to resolve issues
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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