Senior Statistical Programmer

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Everest Clinical Research

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501 - 1000 Mitarbeiter

Gegründet 2004

💊 Pharmazie

🧬 Biotechnologie

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research ist eine globale Clinical Research Organization (CRO), die umfassende Dienstleistungen im Bereich klinische Studien und Biometrics-Expertise für Pharma- und Biotechnologie-Sponsoren bietet. Das Unternehmen offeriert klinische Operationen und Projektmanagement, risikobasiertes Qualitätsmanagement und zentralisiertes Monitoring, medizinisches Monitoring, Pharmakovigilanz, klinisches Datenmanagement, Biostatistik und statistische Programmierung, regulatorische Strategie und Einreichungen sowie Technologielösungen wie IRT/RTSM und ePRO/eCOA. Everest positioniert sich als ein qualitativ hochwertiger Partner mit globaler Reichweite und therapeutischer Expertise in den Bereichen Onkologie, Neurologie, Atemwegserkrankungen, seltene Krankheiten und Immunologie.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• Flexible work arrangements • Professional development opportunities