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    Senior Statistical Programmer - London, United Kingdom - MMS Holdings Inc

    MMS Holdings Inc
    MMS Holdings Inc London, United Kingdom

    1 week ago

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    Description

    MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO inGlobal Health & Pharma'sinternational awards programs for the last three consecutive years. For more information, visit or follow MMS on LinkedIn .

    Senior StatisticalProgrammer

    • Confidently displays excellent internal and external customer service
    • Responsible for implementation and execution of high quality clinical programming
    • Demonstrates strong understanding of ICH guidelines, as applicable to clinical programming
    • Creates and presents programming training exercises, trains new programmers, and serves as mentor
    • Utilizes System Development Life Cycle (SDLC) for programming deliverables
    • Trains via self-study and self-practice independently and explores advanced topics related to programming and/or drug development
    • Interacts directly and independently with client to coordinate all facets of the project; highly competent communicator with excellent client interaction skills
    • Provides high level of support to the statisticians and medical writers on all programming matters according to client requirements
    • Works with statisticians to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphs
    • Generates tables, listings, and graphs from clinical trial databases using SAS
    • Develops programs, verifies, validates, and maintains clinical trial databases and data entry screen using SAS and related software
    • Develops data and programming specifications jointly with other programmers and biostatisticians
    • Designs specific data presentations including creative summary tables, graphs, and patient listings
    • Assists with preparing data validation plan based on customer needs
    • Reviews data management guidelines for computer edit/validation checks
    • Independently implements and validates QC findings in compliance with the NC Handling Procedure
    • Conducts thorough self-reviews of deliverables prior to release to client; serves as high level reviewer for others
    • Follows processes related to project management as appropriate for programmingprojects (e.g. updating VeoProject, updating PSS, close-out procedures etc)
    • Demonstrates extensive knowledge of departmental processes (e.g.competency in programming software and willingness to share information)
    • Takes initiative to suggest and implement programming process improvements and follows through to completion
    • Leads most projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
    • Demonstrates excellent internal and external leadership skills for projects
    • Fully accountable for providing highest quality deliverables of entire project to satisfy or exceed client requirements
    • May produce and present external company presentations providing industry visibility for the organization
    • Accountable for timelines, as well as, internal team interactions
    • Complies with Document Control Procedure
    • Complies with Record Control Procedure
    • Ensures compliance to applicable ISMS policies and procedures

    Job Requirements (Minimum Education / Experience / Training / Skills)

    • Preferably a minimum of 6 years experience in the Clinical Research/Statistical Programming Environment
    • College graduate in computer science or related field, or related experience
    • Has high level knowledge of drug development as it pertains to programming; has the ability to apply drug development knowledge during production of high quality programs
    • Extensive hands-on experience with clinical trials and pharmaceutical development
    • Strong experience with data and production of TLGs
    • Strong programming and logic skills
    • Thorough understanding of CDISC standards and HL-7 standards
    • Extensive experience in pharmaceutical or CRO industry preferred
    • Thorough knowledge of clinical database structures
    • Ability to program data presentations, using program such as SAS procedures
    • Subject matter expert for SAS programming skills; willing to guide others in a variety of programming techniques
    • Strong proficiency with MS Office applications
    • Excellent organizational and communication skills
    • Strong familiarity with ISO 9001:2000 requirements

    Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

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