Senior Statistical Programmer Specialist

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.

• With sufficient experience assume the role of a Lead Statistical Programmer for CP studies only with support from senior programming staff.
• 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 eCRFs and Reviewers Guides to support SDTMs and ADaMs.
• With support from senior programming staff, develop specifications for SDTMs and ADaM datasets.
• Review SAPs and TFL shells from a programming perspective for studies with
• support from senior programming staff.
• Respond to QA and client audits with support from senior programming staff.
• And all other duties as needed or assigned