Principal Statistical Programmer

Summary Of Responsibilities

• 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 Fortrea 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.
• And all other duties as needed or assigned.

Qualifications (Minimum Required)

Experience (Minimum Required)

Physical Demands / Work Environment

Learn more about our EEO & Accommodations request here.

Skills Required

biostatistics , Sas, cdisc, Clinical Data Management, Sdtm, ADAM