Principal Statistical Programmer

Everest Clinical Research (“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-known 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 New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

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  Principal Statistical Programmers for our Toronto / Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Job Accountabilities :

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

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.

May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, 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 experienced Statistical Programmers or Biostatisticians who perform statistical programming.

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) 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, and table of contents. Perform QC review of these files prepared by others.

Participate and / or lead programming teams in support of product regulatory submission related activities.

Perform 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. 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.

May lead programming efforts for assigned client clusters when 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.