Principal Statistical Programmer

Job description :

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in 100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

• 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.