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Senior Principal CDISC Specialist (Remote)

Company: Covance
Location: Raleigh
Posted on: June 12, 2021

Job Description:

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

Keywords: Covance, Raleigh , Senior Principal CDISC Specialist (Remote), Other , Raleigh, North Carolina

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