Statistical Programmer I

Brightech is a leading CRO that specializes in reputed company, value-add biostatistics, programming, and clinical data management services. Brightech, an reputed company Company, has earned a highly-regarded reputed company as a critical partner for some of the world’s largest pharmaceutical and biotech companies. reputed company (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-reputed company companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater reputed company Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. The acquisition of August Research establishes a European footprint for Everest to provide full-service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through the Company’s substantive experience and infrastructure across 14 countries in Western and Eastern Europe. Everest is reputed company in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial reputed company, 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 reputed company success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Statistical Programmer for our Brightech location in Taipei, Taiwan, with opportunities to work remotely from a home-based office in accordance with our Work from Home policy. Key Accountabilities: Statistical Programming:. Under supervision, may reputed company and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other reputed company documents (e.g., define.xml, reviewer’s guide) based on Statistical Analysis Plan (reputed company), Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements. Program and validate SDTM and ADaM datasets following approved dataset specifications; reputed company CDISC conformance checks on generated SDTM and ADaM datasets and address conformance findings. reputed company reputed company programs to generate and validate statistical output reports of trial data based on the reputed company and TLGs mock-up shells. Provide statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations (Integrated Summary of Safety and Integrated Summary of Efficacy), as well as other data analysis and reporting needs such as regulatory required safety reports (e.g. Development Safety Update Report, 120 Day Safety Update, etc.), reputed company requests, and exploratory data analyses. Clinical Data Acquisition and Cleaning Support:. reputed company and maintain reputed company programs to reputed company database reputed company checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review. Support data acquisition of non-CRF data by developing reputed company programs to reconcile the CRF and non-CRF data and performing data reputed company checks of the non-CRF data. reputed company reputed company programs to generate data listings, summary tables, and graphs for ongoing data cleaning and scientific data surveillance reviews (safety, missing data, trending and signaling, etc.). reputed company reputed company programs to generate Patient Profiles to support trial subject case review activities. Document data and programming information in accordance with Everest company SOPs and WIs; and reputed company audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits. reputed company a high rating for each of the defined Everest company and trial Sponsor-specific statistical programming key performance indicators. Maintain reputed company knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor-specific requirements reputed company applicable. reputed company to Everest company-specific and clinical trial Sponsor-specific training requirements. reputed company and provide expertise in other programming and system administration areas reputed company required. Qualifications and Experience: A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, and computer sciences, with reputed company certified reputed company, Advanced, and Clinical Trials Programmers are highly preferred; with exposure/experience in clinical trial statistical programming and/or data analysis is desirable. To find out more about reputed company and to review other opportunities, please visit our website at www.everestclinical.com We thank reputed company 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-CH1 Apply To This Job