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Posted: Friday, September 1, 2017 2:38 PM

Description

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Data Standards Architect – Data Analysis and Reporting to be based in either Spring House PA, Horsham PA, Raritan NJ or Titusville NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.

We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more

The job holder takes a leadership role in the definition and maintenance of standard metadata supporting the data flow from data delivery to data analysis and reporting and in the design, development and maintenance of standards SAS code supporting the creation of analysis datasets and standard tables listings and figures (TLF). The job holder is responsible for implementing efficient standards that cover all trial types and trial designs and for the scientific and operational correctness of the metadata standards in support of the R&D portfolio of drug development programs.


The job holder takes a leadership role in configuring standards to the specific needs and requirements of a Therapeutic Area, compound our Disease Area, generating the expected efficiencies through optimal adoption and reuse of metadata standards and standard SAS code. The job holder also supports the functions adopting the standards in the clinical trials, in close collaboration with the clinical data analysis team. The job holder develops deep expertise in industry standards related to Study Data Tabulation Model (SDTM), Controlled Terminologies (CT), Analysis Data Models (ADaM) and Therapeutic Area User Guides (TAUG). The job holder provides the leadership in managing contractor or flex staff (internal and contractor/flex) responsible for the deliverables described above such as the definition and maintenance of the metadata and SAS code.

PRINCIPAL RESPONSIBILITIES:
  • The job holder is responsible for the definition and maintenance of standard clinical data analysis and results metadata for use in clinical trials. The job holder has is responsible for the mapping -, and derivation metadata used for automating the data flow from Study Data Tabulation Datasets (SDTM) to Analysis Datasets and Analysis Results (ADaM).
  • The job holder consults with the Clinical Data Analysis Standards team for scientific correctness of the metadata, with the Clinical Data Collection Standards team for scientifically correct traceability to the delivery metadata standards and with the Standards Regulatory Intelligence team for the compliance of the metadata with industry regulations.
  • The job holder consults with the Clinical Data Analysis Standards team for scientific correctness of the metadata, with the Clinical Data Collection Standards team for scientifically correct traceability to the delivery metadata standards and with the Standards Regulatory Intelligence team for the compliance of the metadata with industry regulations.
  • The job holder oversees the maintenance of the metadata standards at a master level to meet additional scientific or operational requirement supporting the R&D portfolio.
  • To that end the job holder will guarantee formal change management control and versioning of the standards is applied and adhered to and the job holder governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs.
  • The job holder is responsible for the design, development and maintenance of standard code support the data flow from data delivery (SDTM) to study report. Examples are:
    • Template programs and macros for dataset creation and TLF generation
    • SAS macros for computational algorithms, derivations and wrapper code.
  • The job holder works closely together with the clinical data analysis teams who facilitate the content definition and design of these standards (e.g. display mock-ups).
  • The job holder is responsible for setting up programs and macros compliant to Janssen SOP, guidelines and conventions and for the testing and QC of programs and macro’s. To that end, the job holder collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR) and Quantitative Sciences (QS)
  • The job holder is responsible for delivering the standard programs and macros with related usage and implementation guidelines and documentation for correct adoption in the clinical studies.
  • The job holder is responsible for the standard code over time to meet additional scientific or operational requirement supporting the R&D portfolio and over the application of formal change management control and versioning of the deliverables.
  • To that end, the job holder governs formally all the changes to the code and manages multiple versions in line with adoption needs of the clinical trials and drug development programs.
  • The job holder is responsible for developing SAS code compliant to available set of conventions and practices related achieving code that can be easily shared and maintained.
  • The goal is to develop and maintain code that is generic and that can run on many study designs and meet many study specific situations based on high reliable study metadata specifying the design and study specific situations.
  • The job holder is responsible for developing SAS code compliant to available set of conventions and practices related achieving code that can be easily shared and maintained.
  • The goal is to develop and maintain code that is generic and that can run on many study designs and meet many study specific situations based on high reliable study metadata specifying the design and study specific situations.
  • The job holder will provide the necessary support to the clinical analysis team who facilitate the consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, the job holder will use adoption and conformance metrics to identify potential improvements in the adoption of standards in the studies to maximize the value of standards.
  • The job holder is responsible in acquiring and maintaining deep expertise in the various code development systems applied in the clinical trials such as SAS, LSAF and Pinnacle 21, and in CDISC standards such as SDTM, ADaM, Controlled terminology and define.xml.
  • The job holder is encouraged to become member of industry initiatives related to the development of industry standards.
  • The job holder will interact with other members of the Clinical Development Standards organization and hence needs a workable knowledge of end-to-end (E2E) Data & Analysis Standardization projects, especially those that are dependent on the data collection and delivery standards.
  • In case the actual build of a data collection tool or the definition of metadata is outsourced to a business partner, the job holder is responsible for overseeing the partner, to provide clear and comprehensive requirements to the vendor and to check the deliverables for quality and meeting the requirements.
  • Future looking, the job holder evaluates and implements new industry trend such as biomedical concepts in the metadata structures to create additional efficiencies and quality in applying standards in clinical trials. In this context, biomedical concepts are the relationships and the logic for related groupings of granular concepts in real-world scenarios.


Qualifications
  • BS/BA degree in life sciences or computer science is required
  • 4 years of relevant operational experience in statistical programming is required
  • 2 years of relevant operational experience in clinical data standards is required
  • Proven people management skills is required
  • Proven knowledge of good statistical programming practices is required
  • Experience with Clinical Data Management / Statistical Programming is preferred
  • Experience with SAS based systems is preferred
  • Experience with CDISC standards (SDTM, ADaM, define.xml, etc.) is preferred
  • Experience in providing Subject Matter Expertise to stakeholders is preferred
  • Experience in prioritizing and managing multiple tasks simultaneously. Is required
  • Outstanding written and verbal communication skills in English is required

Johnson & Johnson is an equal opportunity employer



Primary Location
United States-New Jersey-Titusville
Other Locations
North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Data Management
Requisition ID
5802170801

Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=5802170801&lang=en


• Location: South Jersey

• Post ID: 43735938 southjersey
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