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    Senior Statistical Programmer - United Kingdom - EPHARMIT LIMITED

    EPHARMIT LIMITED
    EPHARMIT LIMITED United Kingdom

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Our client is a global pharmaceutical brand who are expanding their programming and statistical teams. They are currently looking for senior level (and above) programmers who will be engaged on inital 12 month contracts on a fully remote basis.

    Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.

    Key requirements include:

    Collaborate with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project, including but not limited to the following:

    Data submission strategy (e.g., managing legacy data, pooling data)

    Responses to regulatory agency queries

    Tables Figures and Listings (TFLs)

    Development Safety Update Reports (DSURs)

    Periodic Benefit-Risk Evaluation Reports (PBRERs)

    Office of Scientific Investigations (OSI) data sets and listings

    Regulatory and/or Payer submission related analysis data sets and/or TFLs

    Associated quality and process documentation as per applicable business processes

    Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets

    Pharmacokinetics/pharmacodynamics data preparation and analysis

    Manipulating and analyzing adjudicated data

    Data preparation and analysis for Global Medical Affairs work

    Clinical Trial Transparency deliverables (data de-identification, results posting files)

    Timely upload of documents to eTMF

    Essential experience/skills:


    • BSc in mathematics, statistics, engineering, computer science, or life or social sciences.


    • Advanced SAS programming knowledge and experience.


    • Knowledge of database set-up and report publishing requirements.


    • Advanced knowledge of technical and regulatory requirements related to the role.


    • Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.


    • Advanced knowledge and experience of clinical drug development or healthcare.

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