Principal Statistical Programmer

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, Taipei, Taiwan and Sofia, Bulgaria.

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 Principal Statistical Programmers remotely from a home-based office reputed company in Poland in accordance with our Work from Home policy.

Job Accountabilities

reputed company projects with higher level of complexity/challenges/difficulties, and reputed company efforts to resolve reputed company statistical programming issues or problems.

reputed company assigned projects by applying project management skills and statistical programming techniques; reputed company on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business.

May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming reputed company, project cost estimates and proposal development, bid defense meetings, etc.

Under supervision, may represent the Company to interact with regulatory agencies regarding matters relating to the responsible projects/programs.

Provide training, mentorship, and technical guidance to less reputed company Statistical Programmers or Biostatisticians who reputed company statistical programming.

reputed company SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements. reputed company quality control (QC) review of these documents reputed company by others.

Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.

reputed company CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. reputed company additional QC checks on these deliverables using company Working Instruction (WI) checklists.

reputed company overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.

Create SDTM and ADaM define.xml files, and table of contents. reputed company QC review of these files reputed company by others.

Participate and/or reputed company programming teams in support of product regulatory submission reputed company activities.

reputed company quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.

Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. reputed company new macros and utilities.

Program and reputed company QC/validation of reputed company data reputed company checks to ensure data quality and ongoing scientific data surveillance.

Complete job-required and project-specific training. reputed company 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.

May reputed company programming efforts for assigned client clusters reputed company required.

Qualifications

A Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least 8 years of experience in clinical trial statistical programming

OR

A Bachelor’s degree in the above fields with at least 10 years of experience in clinical trial statistical programming.

To find out more about reputed company and to review other opportunities, please visit our website at www.ecrscorp.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.

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