About Prilenia Prilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior/Principal Statistical Programmer, to join its team in the US. We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington's disease (HD) and Amyotrophic lateral Sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine. Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine's novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. About the role We seek a highly experienced statistical programmer to join our team. The role is responsible for applying programming methodology for implementing statistical analyses using SAS for in-house deliverables and performing quality review of out-sourced statistical deliverables. This person will also help with submission package planning and responses to inquiries from global regulatory agencies. The ideal candidate will have a strong background in SAS programming for clinical stage biotech companies, with a can-do attitude and the ability to provide expertise in CDISC submission standards and statistical programming for clinical development projects and studies.
The position will report to the Senior Director of Biostatistics and will work closely with Clinical Development, Clinical Operations, and Regulatory Affairs.
*Job level will be determined based on the candidate's experience.
\n Responsibilities:Lead programming activities and provide input on programming methodologies to support the clinical development process.Program and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write clear and robust specifications to describe programming needs.Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.Manage CRO's programming deliverables by reviewing SDTM and ADaM specifications and datasets, and TFL shells and output in collaboration with other Prilenia colleagues.Ensure the quality of internal and external deliverables consistently complies with analysis and reporting standards and regulatory requirements.Assist in submission package planning and providing responses to inquiries from global regulatory agencies.Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.Interact with other internal functions (biostatistics, clinical research and development, regulatory and medical writing). Qualifications and Skills: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. Location/Time ZonesThis is a US-based full-time remote position, with occasional in-person/face-to-face meetings. Flexible schedule with interactions across Israel, North America and Europe time zones.
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