Senior Statistical Programmer

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

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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 multiple complex clinical studies, ensuring high-quality and timely delivery of datasets, analyses, and submission packages • Develop, validate, and review CDISC-compliant SDTM and ADaM datasets, as well as tables, figures, and listings (TFLs) to support clinical study reporting and regulatory submissions • Provide expert guidance on clinical database specifications, data transfer agreements, analysis datasets, TFL shells, and submission documentation • Serve as a programming project lead, managing priorities, resources, study timelines, and stakeholder communications across internal and external teams • Drive compliance with global regulatory requirements and industry standards, including CDISC, FDA, PMDA, ICH, GDPR, and applicable quality procedures • Champion continuous improvement initiatives through the development of programming standards, SAS macros, templates, and operational efficiencies • Mentor, train, and coach Statistical Programmers, Biostatisticians, Data Managers, and other stakeholders on programming processes, standards, and regulatory expectations • Support audits, inspections, proposal reviews, budgets, bid defenses, and sponsor meetings as a subject matter expert in statistical programming

🎯 Requirements

• Degree-level education or an equivalent qualification, combined with a minimum of 6 years of relevant statistical programming experience • Advanced SAS programming expertise, including SAS/Macro, Proc Report, ODS, Proc SQL, SAS/STAT, and related programming applications • Extensive experience creating and reviewing CDISC SDTM and ADaM datasets, TFLs, and electronic submission deliverables • Demonstrated experience providing technical leadership and programming oversight for complex clinical studies and projects • Strong understanding of regulatory submission requirements and industry standards, including CDISC, FDA, PMDA, ICH, GDPR, and Good Clinical Practice (GCP) • Proven ability to lead projects, manage competing priorities, and collaborate effectively with sponsors and cross-functional teams • Excellent analytical, problem-solving, communication, mentoring, and training skills, with exceptional attention to detail • Proficiency in English

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