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
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
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