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

Qualifications (Minimum Required)

• 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.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills Required: Speaking: English Required Writing/Reading: English Required

Experience (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.
• 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

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 training.

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