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SlipStream I.T. Inc

SAS Programmer - Regulatory and Life Sciences Research

SlipStream I.T. Inc, Butler, Pennsylvania, United States, 16001

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SAS Programmer - Regulatory and Life Sciences Research The SAS Programmer with a strong background in real-world evidence (RWE) analytics to support the development, transformation and analysis of real-world data (RWD) form sources such as electronic health records (EHR), claims and registries. The ideal candidate will bring 5+ years of SAS programming experience, including hands-on development of analytical datasets and outputs for observational and non-interventional studies, with a focus on delivering regulatory-quality deliverables. The role will partner closely with biostatisticians/epidemiologists, medical writers and CDISC programmers to produce transparent, reproducible, and compliant analyses that support regulatory submissions, publications, and value dossiers. Responsibilities: Complete fit-for-purpose analysis of real-world datasets for regulatory studies Develop, validate and maintain SAS programs for the preparation of RWE study datasets, statistical outputs, and submission-ready tables, listings, and figures (TLFs). Program analytical datasets from raw real-world data sources (eg, EHR, claims, registry data), ensuring accuracy, completeness, and traceability. Conduct quality control and peer review of programming deliverables to ensure alignment with study specifications and SOPs Document programming process to clearly supports reproducibility and audit readiness for regulatory review. Conduct verification of other's SAS code Collaborate with cross-functional teams including medical writers, biostatisticians, CDISC programmers and clients. Ensure adherence to internal SOPs, ICH guidelines, FDA RWE guidance, and other global regulatory standards. Qualifications: Education level: BS or MS in computer science, statistics, epidemiology. Experience: At least 5 years' experience in SAS programming. Special Skills: Strong understanding of real-world data structures, including claims, EHR, and registry data. Experience in RWE study design and programming retrospective cohort, natural history/burden of illness, and comparative effectiveness studies. Strong documentation skills, including version control and commenting for traceability. Familiarity with CDISC and previous use of Veeva Vault is preferred but not required. Personal characteristics. High level of collaborativeness to effectively work across teams (epidemiology, medical writing, regulatory). Due to the remote nature of work, individual must be driven to meet timelines without direct oversight. Certifications. N/A Licenses. N/A Physical abilities. N/A Travel: N/A Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time. This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at anytime at the sole discretion of the Employer. #J-18808-Ljbffr