Principal Statistical Programmer - Canada - Everest Clinical Research

    Everest Clinical Research
    Everest Clinical Research Canada

    1 month ago

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    Principal Statistical Programmer (Remote)



    Principal Statistical Programmer | Everest Clinical Research |Canada

    Everest Clinical Research ("Everest") is a full-servicecontract research organization (CRO) providing a broad range ofexpertise-based clinical research services to worldwide pharmaceutical,..

    Login to continue Everest Clinical Research ("Everest") is a full-servicecontract research organization (CRO) providing a broad range ofexpertise-based clinical research services to worldwide pharmaceutical,biotechnology, and medical device industries.

    We serve some of thebest-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 foundationas a statistical and data management center of excellence.

    Building on thisfoundation, Everest has successfully developed and established itself as afull-service CRO.

    Everest's headquarters are located in Markham (GreaterToronto Area), Ontario, Canada with additional sites in Bridgewater(Greater New York City Area), New Jersey, USA, Shanghai (Pudong ZhangjiangNew 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. Adynamic organization with an entrepreneurial origin, Everest continues toexperience exceptional growth and great success.
    Quality is our backbone, customer-focus is our tradition, flexibility isour 's 's Everest.

    To drive continued success in this exciting clinical research field, weare seeking committed, skilled, and customer-focused individuals to joinour winning team as Principal Statistical Programmers forour Toronto/Markham, Ontario, Canada on-site location, or remotely from ahome-based office anywhere in Canada in accordance with our Work from Homepolicy.


    Job Accountabilities:
    Lead projects with higher level ofcomplexity/challenges/difficulties, and lead efforts to resolve complexstatistical programming issues or problems.

    Lead assigned projects by applying project management skills andstatistical programming techniques; achieve on-time delivery ofdeliverables with quality, as well as earn client's trust and repeatbusiness.

    May represent the Company in interactions with clients regardingstatistical programming projects and relevant businesses, such asprogramming oversight, project cost estimates and proposal development, biddefense meetings, etc.

    Under supervision, may represent the Company to interact with regulatoryagencies regarding matters relating to the responsibleprojects/programs.
    Provide training, mentorship, and technical guidance to less experiencedStatistical Programmers or Biostatisticians who perform statisticalprogramming.

    Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISEfollowing company's or client's Standard Operating Procedures (SOPs)and project specific requirements.

    Perform quality control (QC) review ofthese documents prepared by others.

    Program and validate SDTM and ADaM datasets following approved datasetspecifications for CSRs, ISS, and ISE.Perform CDISC standard compliant checks on SDTM and ADaM datasets.

    Generate, review, and resolve Pinnacle 21 validation issues. Performadditional QC checks on these deliverables using company WorkingInstruction (WI) checklists.
    Perform overall quality/consistency review of statistical TLGs beforedelivering them to the internal team or the client.
    Create SDTM and ADaM files, and table of contents. Perform QCreview of these files prepared by others.
    Participate and/or lead programming teams in support of productregulatory submission related activities.
    Perform quality review/assessment on regulatory submission programmingdocuments, datasets, computer programs, etc.
    Learn and maintain expertise in the use of the utilities and macrosdeveloped for the Statistical Programmers. Develop new macros andutilities.
    Program and perform QC/validation of complex data integrity checks toensure data quality and ongoing scientific data surveillance.
    Complete job-required and project-specific training. Comply withapplicable Everest and trial Sponsor's Policies, SOPs, and WIs.
    Document data and programming information in accordance with corporateSOPs and guidelines.
    Archive clinical trial data (SDTM and ADaM datasets) and programminginformation in accordance with corporate archival SOPs and guidelines.
    May lead programming efforts for assigned client clusters whenrequired.


    Qualifications:
    A Master's or Ph.
    D.

    degree in Statistics, Biostatistics,Epidemiology, and Computer Sciences, with at least 8 years of experience inclinical trial statistical programmingORA Bachelor's degree in the above fields with at least 10 years ofexperience in clinical trial statistical programming.

    To find out more about Everest Clinical Research and to review otheropportunities, please visit our website at thank all interested applicants, however, only those selected for aninterview will be contacted.

    Everest is committed to upholding the principles of dignity,independence, integration, and equal opportunity.

    We welcome and encourageapplications from people with disabilities, and upon request we willprovide accommodations for candidates participating in any part of ourrecruitment and selection process.


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