Statistical Programmer.

    CSL Behring
    King Of Prussia, PA 19406
    Full-time, Part-time

    Job Description

    With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

    CSL is the parent company of CSL Behring and Seqirus. CSL Behringis a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

    We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

    • Collaborates with peers and the study statistician to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content. Generates the production and/or validation efforts for the designed output when not outsourced to CROs.
    • Collaborates with peers and statisticians to ensure the quality and accuracy - thus submission readiness - of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml). Supports the review of related deliverables when provided by CROs.
    • Responsible for programming (production or validation) requested efforts for pooled and exploratory analyses working closely with clinical programming team and their collection of legacy data.
    • Responsible for programming (production or validation) of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
    • Works with peers to program complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
    • Works with peers to develop global tools that increase the efficiency and capacity of the Statistical Programming group.
    • Works closely with peers to ensure that assigned task timelines are met with high quality deliverables.
    • Additional tasks:
    • Supports CR&D staff in data analysis requests.
    • Performs additional statistical analyses including but not limited to:
      • support responses to regulatory agencies,
      • generate integrated summary of safety and efficacy,
      • support publications and presentations,
      • support planning and reporting of clinical trials via exploratory analyses of available data,
      • replicate CRO and CSL statistician analyses for QC
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    Posting ID: 554947771Posted: 2020-07-02