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):

• Bachelors 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

Experience (Minimum 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 Reviewers Guide and submission standards.

Physical Demands/Work Environment:

• 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.

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