Senior Statistical Programmer

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🕒 June 5

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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

• Flexible work arrangements • Professional development opportunities