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    Senior Statistical Programmer - Canada - Everest Clinical Research

    Everest Clinical Research
    Everest Clinical Research Canada

    2 weeks ago

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    Senior 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 Senior Statistical Programmers for ourToronto/Markham, Ontario, Canada on-site location, or remotely from ahome-based office anywhere in Canada in accordance with our Work from Homepolicy.


    Key Accountabilities:


    Lead efforts in resolving day-to-day work-related issues andproblems, ensuring quality of deliverables, as well as improving theefficiency and productivity of statistical programming work.

    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.

    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) QC checklists.
    Perform overall quality/consistency review of statistical TLGs beforedelivering them to the internal team or the client.
    Create SDTM and ADaM files. Perform QC review of these filesprepared by others.
    Participate and/or lead programming teams in support of productregulatory submission related activities.
    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.


    Qualifications:
    A Master's or Ph.
    D.

    degree in Statistics, Biostatistics,Epidemiology, and Computer Sciences, with at least four years' experiencein clinical trial statistical programmingORA 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 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.


    Show more Show lessTagged as:
    remote, remote job, virtual, Virtual Job,virtual position, Work at Home, work from home

    When applying state you found this job on Remote Network.

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