Senior Statistical Programmer at Everest Clinical Research

Poland

We’re Growing in Poland! Everest Clinical Research is a global Clinical Research Organization that proudly maintains a regional clinical operations hub in Warsaw.  Now, Everest's global biometrics team is embarking on an exciting phase of growth, and we're thrilled to announce the biometrics team’s expansion in Poland with the establishment of a dedicated biometrics group. Over the next 6 months, Everest plans to build a dynamic team of 20 talented professionals who are passionate about biometrics. If you’re driven by data, eager to make a meaningful impact, and want to be part of a Statistical and Data Management Center of Excellence, we invite you to join our global biometrics team and help shape the future of clinical research. Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Statistical Programmers remotely from a home-based office near Warsaw, Poland in accordance with our Work from Home policy. Key Accountabilities: 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. Qualifications: 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 OR A Bachelor’s degree in the above fields with at least six years’ experience in clinical trial statistical programming.   To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com [http://www.ecrscorp.com].  We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-TK1