Senior Statistical Programmer

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🕒 March 27

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, as well as improving the efficiency and productivity of statistical programming work. • Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business. • Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements. • Perform quality control (QC) review of these documents prepared by others. • Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE. • Perform CDISC standard compliant checks on SDTM and ADaM datasets. • Generate, review, and resolve Pinnacle 21 validation issues. • Perform additional QC checks on these deliverables using company Working Instruction (WI) QC checklists. • Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client. • Create SDTM and ADaM define.xml files. • Perform QC review of these files prepared by others. • Participate and/or lead programming teams in support of product regulatory submission related activities. • Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. • Develop new macros and utilities. • Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance. • Complete job-required and project-specific training. • Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs. • Document data and programming information in accordance with corporate SOPs and guidelines. • Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.

🎯 Requirements

• A Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least four years’ experience in clinical trial statistical programming • A Bachelor’s degree in the above fields with at least six years’ experience in clinical trial statistical programming.

🏖️ Benefits

• Work from Home policy