Statistical Programmer II – Sponsor Dedicated

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Fortrea

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.

📋 Description

• Lead or support programming activities for complex phase I–III clinical trials • Plan, execute, and oversee study programming activities, including resource estimation, budget management, timelines, quality, and cross-functional/client interaction • Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs • Perform QC of SDTM, ADaM datasets, and TFLs • Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs, and Review Guides • Develop SDTM and ADaM dataset specifications with senior programming support • Review SAPs and TFL shells from a programming perspective • Respond to QA and client audits with senior programming support • Perform other assigned duties

🎯 Requirements

• Minimum Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects • Typically 1–2 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience • Knowledge of CDISC requirements • Business fluency in English, spoken and written

🏖️ Benefits

• 100% home-based work option • Option to work from a local office in your home country • Opportunity to lead studies through various phases of the clinical development plan • Support for submissions, regulatory questions, publications, and ad hoc/post hoc requests

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