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.
  
  

• 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 Bachelors degree.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills Required: o Speaking: Yes, English required o Writing/Reading: Yes, English required
  
  

• Typically, 6 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.
• Experience as lead statistical programmer on complex studies in clinical research.
• Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g., Biostatistics and Clinical Data Management.
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewers Guide and submission standards.
  
  

• Office or home-based environment, as requested by the line manager.
• Travel Requirements: Yes.
• Local, Domestic, Regional, Global.
• % of time dedicated to travel: 5%.
• % of the above that requires overnight stay: Approximately up to 100%.
• Travel is primarily to where: client meetings and trainings.