Hiring forSenior Principal Statistical Programmer (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 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 programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead processes, 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 of statistical programming

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

Minimum Required:

• Typically 8 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
• Extensive experience as lead statistical programmer on complex studies in clinical research
• Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion.
• Complete knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards