Quanticate UK - Head Office

  • Subject Matter Expert CDISC (ADaM and SDTM)

    Job Locations UK-Hertfordshire-Hitchin | UK-Cheshire-Wilmslow | UK-Midlothian-Edinburgh | UK-Home Based
    Posted Date 2 weeks ago(5/11/2018 6:20 AM)
    # of Openings
  • Overview

    Quanticate are looking for two SAS Programming Subject Matter Experts (SME) who have extensive experience working in CDISC (ADaM and SDTM) to provide technical expertise in the development of processes and initiatives, in order to allow the programming and statistics teams to deliver, ensuring that current Quanticate, client specific standard operating procedures (SOPs) and processes as well as applicable regulatory requirements are adhered to at all times.

    We are looking for one Subject Matter Expert CDISC ADaM and one Subject Matter Expert CDISC SDTM.




    Your core responsibilities will be to:


    • Define the business processes, the business policies and the technical requirements for initiatives to help drive industry standards and to deliver key company objectives
    • Understand, articulate and implement best practice related to CDISC
    • Design and deliver training to a range of staff, increasing their competence and understanding of your subject matter area and beyond
    • Input to proposals and bid defence meetings or other Business Development activities on specifics related to CDISC
    • Ensure that CDISC content produced is accurate and appropriate
    • Cultivate and maintain effective working relationships with a variety of stakeholders, including end-users, project managers, IS, and senior staff members
    • Participate in multiple work-groups, and disseminating information across all levels of the organisation
    • Articulate and communicate information effectively to diverse audiences
    • Translate the terminology into business terms, making appropriate recommendations of improvements and/or alternatives to both senior management and software developers
    • Perform demonstrations in a variety of settings, including internal meetings and training sessions
    • Act proactively to add value and follow up to ensure problems remain solved
    • Take ownership for your continuous professional development and undertake assigned development activity in your role
    • Carry out other reasonable management requests dependent on the needs of the business
    • Provide advanced input into projects requiring CDISC, setting internal timelines and priorities and directing specific project work ensuring targets for delivery to time, quality and budget are met
    • Lead and/or or be an active participant of a work-group where there is a need for specialised knowledge
    • Train other staff in all elements of your area of expertise ensuring a range of materials and training interventions are used to meet different learning styles
    • Provide guidance on how their area of capability can resolve an organisational need
    • Anticipate customer needs and do everything to meet them through effective relationship building and taking full accountability and ownership for areas of responsibility
    • Identify gaps and flaws within processes and suggest alternative ways of working to improve quality of service
    • Review progress of own work and that of others feeding back training needs and areas for improvement to Line Managers to drive performance standards
    • Reduce waste and improve quality in individual work tasks, raising ideas for improved services, products or efficiencies
    • Identify gaps in resource plans related to functional expertise area and work with central resourcing team to assign tasks to resources
    • Provide regular feedback to management and/or the central resourcing team if any action is needed to increase utilisation, improve efficiency
    • Deliver excellent customer care in support of genuine value and enhancing the customer experience including high level of interaction with external and internal clients on study related issues as determined by the needs of the project
    • May mentor or line manage a small number of programmers



    In order to be considered for this role, you will demonstrate the following key skills and attributes:


    • Qualified to degree level or equivalent, preferably in a numerate or scientific discipline
    • Extensive experience of statistical programming within the pharmaceutical industry or medical sector, having an experience of a number of activities from study set up to final reporting
    • Knowledge and experience of the requirements for the delivery of clinical trials within the pharmaceutical industry
    • Knowledge of clinical and pharmaceutical drug development
    • Understanding of the basic principles of statistics
    • Excellent SAS Programming ability
    • Ability to design and deliver training material enhancing the skills, knowledge and competence of our technical teams
    • Advanced level in all Microsoft Office packages
    • Excellent organisational and time management skills with the ability to prioritise a number of deadlines
    • Thorough analytical skills and attention to detail
    • Effective presentation skills to motivate and engage others in CDISC
    • The ability to effectively communicate technical information both orally and in writing to a wide range of stakeholders
    • A focus on continuous improvement to enhance business performance
    • Influencing and negotiation skills


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