Hiring for Senior 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 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 by Labcorp 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

Recommended:

• BSc, preferably in computing, life science, mathematical or statistical subject

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

• Deep knowledge of CDSIC (SDTM/ ADaM standards)

• 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