Principal Statistical Programmer, FSP (Remote)

Job Overview:

Hiring for Principal Statistical Programmer (Remote) FSP: can be based anywhere in USA/ Canada #LI-REMOTE

  • Perform the role of the Lead Statistical Programmer.
  • 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 Drug Development 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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