Senior/Principal Statistical Programmer SAS + R (Remote)Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our general pharmaceutical clients; The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.

This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. Xml files for multiple studies ~ Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs ~ Deliver high-quality statistical programming results including developing, validating,



and maintaining SAS and/or R programs tailored to clinical development programs' needs ~ Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines ~ Understand and follow FDA regulations which affect the reporting of clinical trial data. Participate in the development of CRFs, edit check specifications, and data validation plans ~ Provide review and/or author data transfer specifications for external vendor data ~ CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals ~ Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred ~7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies ~ Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment ~ Xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation ~ Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities ~ Prior work experience with pharmacokinetic data and the neuroscience field, ~ proficiency in languages or tools other than SAS (e.R, Python, and Java, Shiny, Markdown, Unix/Linux and git) Cytel Inc. is an Equal Employment / Aff...

📌 Farmacéutico/A Teruel (Aragón)
🏢 Empresa de gestión y selección
📍 Aragón