Senior Statistical Programmer

October 20

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Description

• About Prilenia • Prilenia Therapeutics is looking for a Senior/Principal Statistical Programmer. • We are a flexible, fast-moving team impacting lives of patients and families. • Our lead product candidate, pridopidine, addresses HD disease progression. • The role involves implementing statistical analyses using SAS for in-house deliverables. • Help with submission package planning and regulatory inquiries. • Report to the Senior Director of Biostatistics and collaborate across teams.

Requirements

• Graduate degree in statistics, biostatistics, mathematics, computer science, biotechnology, or a related field with at least 7 years (or bachelor’s degree with at least 10 years) of SAS programming experience in Biotech, Pharma, Clinical Research Organizations (CRO), or other relevant organizations. • Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) is required. • Clear understanding of the drug development process, submission-related activities and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP). • Ability to effectively communicate and perform in a high demand and dynamic working environment. • Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment. • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity. • Must be able to work under pressure, manage time, set priorities and meet deadlines.

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