Senior Biostatistical Programmer

Are you a highly motivated and experienced biostatistical programmer looking to advance your career in oncology clinical trials?

We are seeking a Senior Biostatistical Programmer to join our team at Fortrea, a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience.

In this role, you will have the opportunity to work on complex studies in Phases I-II, collaborating with cross-functional teams to deliver high-quality results. Your expertise as a Lead Statistical Programmer will be invaluable in planning, executing, and overseeing all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.

As a Senior Biostatistical Programmer, you will develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, perform QC of SDTM, ADaMs, and TFLs, and produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTMs and ADaMs.

• Develop and lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Covance 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-experienced 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.

• Degree, preferably in computing, life science, mathematical or statistical subject.
• Experience as lead statistical programmer on complex studies in clinical research company.
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide, and submission standards.
• Candidates must be fluent in English language (both verbal and written).

As a Senior Biostatistical Programmer at Fortrea, you can expect a competitive salary range of $95,000 - $135,000 per year, depending on experience and qualifications, plus benefits, including health insurance, retirement plan, paid time off, and professional development opportunities.