Senior Statistical Programmer 2

🔥 2 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Lead statistical programming activities across complex clinical studies • Ensure high-quality delivery, effective resource planning, and alignment with project scope and budgets • Develop, test, validate, and review SAS programs • Generate CDISC SDTM and ADaM datasets, tables, figures, listings, and other clinical study deliverables • Provide expert guidance on clinical database specifications, data transfer requirements, dataset specifications, and statistical reporting outputs • Serve as a subject matter expert in CDISC standards, electronic data submissions, and global regulatory requirements • Oversee preparation and review of submission-ready documentation, including annotated CRFs, define.xml packages, reviewer guides, and analysis metadata • Drive continuous improvement through programming standards, SAS macros, SOPs, templates, and quality management documentation • Mentor, coach, and train Statistical Programmers, Biostatisticians, Clinical Data Managers, and other stakeholders • Support proposal reviews, budget assessments, bid defense activities, audits, inspections, and sponsor interactions • Ensure compliance with quality and regulatory requirements

🎯 Requirements

• Bachelor's degree or equivalent education • At least 6 years of relevant statistical programming experience within a clinical research environment • Advanced SAS programming expertise, including SAS/Macro, Proc Report, ODS, BASE SAS, SAS/Graph, Proc SQL, and SAS/STAT • Experience leading programming activities for complex clinical studies and providing technical leadership to project teams • Strong knowledge of CDISC standards, including SDTM and ADaM • Experience preparing regulatory submission packages and supporting health authority requirements • Experience developing and reviewing clinical study datasets, TFLs, specifications, reviewer guides, and related submission documentation • Strong analytical, problem-solving, and detail-oriented skills • Ability to manage multiple priorities and deliver high-quality results • Ability to mentor, train, and support colleagues and cross-functional partners

🏖️ Benefits

• Collaborative and inclusive environment • Growth and career development opportunities • Learning, mentoring, and training opportunities • Opportunity to contribute to innovation and continuous improvement • Global team collaboration