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Senior Statistical Programmer

Overview:

  • Duties and Responsibilities:
    • Responsible for the production of SDTM and/or ADaM datasets to the required specification.
    • Produce Define. XML/PDFs, aCRFs and Reviewers Guide to support SDTM and ADaM deliverables.
    • Read-in and reconcile electronic data with the CRF.
    • Develop SAS programmable edit checks to assist in data review as needed.
    • QC datasets, defines, aCRF and Reviewers Guide to ensure their accuracy and meet the client specifications and documented appropriately in JIRA
    • Responsible for the production of data tables, figures and listings (TFLs) to the required specification for clinical, PK and PD reports in SAS.
    • QC TFLs to ensure their accuracy and meet the client specifications and documented appropriately in JIRA
    • Produce PK merge / EDT file
    • Take on responsibility for studies to ensure the datasets and/or TFLs and associated documents are completed in a timely manner and to the required specification
    • Responsible for timely data transfer to and from clients in both production and developmental roles.
    • Interact with clients on SAS programming matters.
    • Review and comment on the Statistical Analysis Plan and TFL shells.
    • Take on responsibility for program of studies to ensure the SAS outputs and associated documentation are consistent across studies and ensure Programmers are trained in client specific requirements
    • Answer QA audits in an accurate and timely manner.
    • Provide guidance, mentoring, training and feedback for members of the department in SAS processes and programming techniques.
    • Provide departmental training where appropriate.
    • As a Lead Programmer attend and contribute at all study meetings.
    • Liaise with supervisor to ensure that studies are scheduled into the department schedule.
    • Liaise with external and internal clients as required with regard to requirements for SAS deliverables and attend client meetings where required.
    • Liaise with study team to ensure targets and timelines are achieved.
    • Perform ad-hoc programming in response to unscheduled requests.
    • Ensure that all study material (paper and electronic) are archived within 3 months of the end product going final.
    • Contribute at department meetings, presenting SAS coding items to the rest of the department.
    • Ensure quality of personal work.
    • Investigate and implement new procedures / methods when necessary.
    • Proactive involvement with process improvements.
    • Good time management and organization skills, the ability to prioritize own work to meet tight deadlines while maintaining the highest standards of work.
    • Effective communication skills; a co-operative and team orientated approach.
    • Perform other related duties as assigned.

    Education/Qualifications

    University/college degree or HND in a numerate or computing discipline.

    Experience

    • 3-4 years of SAS programming experience.
    • Experience with relational databases.

    Understanding of data management and the clinical trial process



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