Ipsen Pharma - Cambridge Springs, PA
posted 5 months ago
The Principal Statistical Programmer at Ipsen Biopharmaceuticals, Inc. will play a crucial role in the production and quality control of programming related to clinical trials, particularly in the area of rare diseases. This position involves project coordination and oversight of vendor programming, ensuring that all clinical datasets meet the necessary standards for regulatory submissions, including INDs and NDAs/MAAs. The successful candidate will be responsible for statistical programming activities, which include analyzing, integrating, and reporting clinical trial data to produce high-quality and timely deliverables. The role requires proficiency in SAS programming for data analysis, as well as the generation of derived analysis datasets, tables, listings, and figures for Clinical Study Reports and regulatory submissions. In addition to programming responsibilities, the Principal Statistical Programmer will be tasked with the creation and quality control of CDISC SDTM and ADaM files, SAS export files, and Define.xml for electronic submissions. The position also involves full QC validation of in-house created graphs, tables, and figures, and requires interaction with statisticians, programmers, and other clinical team members to perform ad hoc analyses and generate outputs according to specific requirements. The candidate will review and provide feedback on CRFs, annotated CRFs, Data Management Plans, and other study-related documents, participating in operations meetings to address any issues that may impact statistical programming and data management. The role demands collaboration with CRO statisticians and statistical programmers, reviewing and quality checking their work and deliverables. A solid understanding of clinical trial design and reporting processes, as well as regulatory reporting requirements, is essential. The Principal Statistical Programmer will need to manage multiple projects and deadlines in a fast-paced environment, demonstrating the ability to adapt to shifting priorities and resources.