Overview

Job Overview:

Hiring for Senior Principal CDISC Specialist (Remote): can be based anywhere in USA/ Canada

  • Perform the role of a Lead Statistical Programmer including leading oversight of partnership programs
  • Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
  • Develop and maintain SAS programs to create complex SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
  • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
  • Develop and/or lead the development of complex specifications for SDTMs and ADaM
    datasets and contribute to the development of Covance by Labcorp and Client standards
  • Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
  • Mentor programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead processes, ensuring adherence to department practices and processes
  • Facilitate advanced technical expertise
  • Respond to QA and client audits and represent the department in all types of audits
  • Participate in partnership Bid Defenses in order to win new packages of business
  • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

Education/Qualifications:

Recommended:

  • BSc, preferably in computing, life science, mathematical or statistical subject

Experience:

Minimum Required:

  • Typically 8 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Deep knowledge of CDSIC (SDTM/ ADaM standards)
  • Extensive experience as lead statistical programmer on complex studies in clinical research
  • Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion.
  • Complete knowledge and understanding of the processes and procedures used within a Statistical
    Programming environment and the ability to communicate to programmers and non-programmers
    alike.
  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer’s Guide and submission standards

Tagged as: MID TO SENIOR LEVEL