Principal Statistical Programmer - Oncology

November 1

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Fortrea

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Description

• Perform the role of the Lead Statistical Programmer. • Plan, execute and oversee all programming activities on a study. • Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs. • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides. • Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets. • Review SAPs and TFL shells from a programming perspective for studies. • Mentor less-experience 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. • Contribute to proposal activities and participate in bid defenses meetings. • Continually identify and suggest ways to improve the efficiency, quality, and productivity of statistical programming.

Requirements

• 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. • Typically, 6 years of SAS® programming experience in the CRO or Pharmaceutical industry. • Experience as lead statistical programmer on complex studies in clinical research. • Needs Oncology lead experience. • Typically, 3-5 years of Oncology experience. • Submissions experience is preferred. • Knowledge in all aspects of clinical trials from initial study set-up to study completion. • Broad knowledge of all CDISC requirements related to SDTM and ADaM.

Benefits

• Medical • Dental • Vision • Life • STD/LTD • 401(K) • ESPP • Paid time off (PTO) • Flexible time off (FTO) • Company bonus where applicable.