Principal Statistical Programmer (Remote)

Laboratory Corporation of America Holdings (Covance)

Durham, North Carolina, United States

Job Overview: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 Covance 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:Recommended: BSc, preferably in computing, life science, mathematical or statistical subject 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

2020-07-20 15:44:21

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