
10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
🔥 7 hours ago
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10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
• Perform the role of the Lead Statistical Programmer • Plan, execute, and oversee all programming activities on a study, including resource estimation, budget management, timelines, quality, and interaction with departments and clients • Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs • Perform quality control of SDTM, ADaMs, and TFLs • Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Review Guides • Develop specifications for SDTM and ADaM datasets • Review SAPs and TFL shells from a programming perspective • Mentor less-experienced programmers on SDTMs, ADaMs, and TFLs • Present and share knowledge at department meetings • Respond to QA and client audits and support qualification audits • Identify programming processes that improve productivity, quality, and efficiency • Perform other duties as needed or assigned
• Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects • Experience and/or education plus relevant work experience, equating to a Bachelor's degree • Relevant and equivalent experience may be considered in lieu of educational requirements • English required for speaking, writing, and reading • Typically, 3–5 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience • Knowledge of CDISC requirements • Willingness and ability to travel locally, domestically, and regionally • Approximately 5% travel, with overnight stays required for up to 100% of travel
• Office or home-based environment, as requested by the line manager • Travel to client meetings and trainings • EEO and accommodations support
Apply Now🔥 8 hours ago
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