Senior Principal Statistical Programmer

Company: Labcorp
Location: Durham
Posted on: August 6, 2022

Job Description:

The Senior Principal Statistical Programmer performs 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. What to Expect

• 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 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
• 100% Remote anywhere in the US or Canada Education/Qualifications
  • 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 Experience
    • 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 standard Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.For more information about how we collect and store your personal data, please see our Privacy Statement .

Keywords: Labcorp, Durham , Senior Principal Statistical Programmer, IT / Software / Systems , Durham, North Carolina