Senior Statistical Programmer

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Sitero

WebsiteLinkedInAll Job Openings

201 - 500 employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

☁️ SaaS

Healthcare Insurance • Pharmaceuticals • SaaS

Sitero is a next-generation clinical trial solutions provider that accelerates clinical trials, ensures compliance and safety, and enables innovation through advanced technology and world-class services. They offer a wide range of clinical services, including site support and activation, data management, biostatistics, and drug safety. Sitero specializes in eClinical technology, providing end-to-end, technology-enabled services such as electronic data capture, randomization and trial supply management, clinical trial management systems, electronic consent solutions, and payment systems. Their services also include IRB ethical review, biosafety consulting, and pharmacovigilance agreements, ensuring comprehensive support for clinical research organizations.

📋 Description

• Create and validate edit check programs using standard validation practices. • Develop SAS programs to convert data from EDC to protocol-specific SAS datasets. • Review and annotate CRFs for SDTM mapping. • Provide statistical programming support to generate ADaM datasets, tables, listings, and figures for individual studies (both safety and efficacy) and ISS/ISE studies. • Apply advanced knowledge of CDISC standards (SDTM and ADaM) across all deliverables. • Run P21 reports for both SDTM and ADaM datasets and interpret the results. • Develop and validate SAS macros and format libraries. • Ensure the quality of client data and data exports. • Create documentation related to the generation of customer-specific SAS datasets. • Maintain the SAS environment, including assistance with installation, updates, and maintenance. • Review and approve User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents. • Develop and implement new CDM systems and enhancements to current CDM systems. • Understand, create, and communicate information about creating CDISC-compliant datasets. • Assist the Study Quality Representative in testing protocol-specific SAS conversion programs. • Proactively manage concurrent activities within a study or project. • Assess and assign target dates for project timelines in collaboration with the manager. • Adhere to project target dates and communicate any changes to appropriate personnel, including the Project Manager.

🎯 Requirements

• Bachelor’s degree in Computer Science, Statistics, or a related field — required • 8+ years of SAS programming experience in a pharmaceutical or clinical research industry environment — required • 5+ years of experience working with CDISC standards, SQL, and relational databases — required • 3+ years of experience with database organization and data extraction for listings and reports — required

🏖️ Benefits

• competitive base salary • paid time off • comprehensive healthcare and retirement benefits