Programming Lead

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 SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
• Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs
• Reviewers Guides to support SDTMs and ADaMs.
• Develop specifications for SDTMs and ADaM datasets.
• Review SAPs and TFL shells from a programming perspective for studies.
• Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs.
• Present and share knowledge at department meetings.
• Respond to QA and client audits, and support qualification audits.
• Identify processes within programming that will increase productivity, quality, and efficiency.
• All other duties as needed or assigned