Join to apply for the SAS Programmer role at Katalyst CRO Overview The statistical programming contractor independently manages completed projects that involve global tasks or cross functional teams. The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, the role provides programming support for publication for our marketed drugs. Responsibilities Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLGs. Provide comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLGs) complying with regulatory requirements, departmental SOPs and work practices. Provide programming support to CDISC based e-submission. Manage and deliver assignments with good quality and within timelines; work independently and proactively. Standardize GSD deliverables (datasets and associated TLGs) across study projects within an indication/therapeutic area. Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate project status and resource gaps to management. Provide input on opportunities for process improvement; proactively communicate issues impacting programming deliverables with Stat or DM team members. Support publication programming for marketed drugs when applicable. Qualifications Bachelor's or Master's degree in science, Statistics, Information Technology or equivalent combination of education and related work experience. Proven experience (7+ years with Bachelor’s, 6+ years with Master’s) in a pharmaceutical or clinical research setting as a programmer. Proficient knowledge of clinical trials and drug development processes, industry standards, and statistical concepts used in analysis and submissions of clinical trial data. Strong understanding of CDISC SDTM and ADaM standards and implementation guides. Demonstrated proficiency in using SAS to produce analysis datasets, TLGs, eSUB components, and other software applications. CDISC based e-submission expertise, including creation of ADaM datasets and associated TLGs. Solid knowledge of statistical models used for efficacy data analysis and government regulations (CDISC, ICH) across multiple therapeutic areas. Excellent oral and written communication skills; ability to work independently and in a team environment. Seniority level Mid-Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO
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