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Labcorp Principal Statistical Programmer (Remote) in Helana, Montana

Job Overview:

  • Perform the role of the Lead Statistical Programmer. o 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 complete 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 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 less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes

  • Present and share knowledge at department meetings

  • Respond to QA and client audits and support qualification audits

  • Contribute to proposal activities and participate in bid defenses meetings in order to win new business

  • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

Education/Qualifications:

Minimum Required:

  • Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.

  • Experience and/or education plus relevant work experience, equating to a Bachelor's degree

Experience:

Minimum Required:

  • Typically 6 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 

  • Experience as lead statistical programmer on complex studies in clinical research 

  • Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management. 

  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards

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