Hiring forSenior 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 Guidesto 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 thedevelopment of complex TFL shells from a programming perspective
Mentor programmers in the processes around SDTMs, ADaMs and TFLs and Study Leadprocesses, 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 ofstatistical programming
Recommended:
Minimum Required:
Deep knowledge of CDSIC (SDTM/ ADaM standards)