Senior/Principal Statistical Programmer SAS + R (Remote)

Principal Statistical Programmer responsibilities include generating SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies; developing SAS programs to generate datasets, complex listings, tables and graphs; delivering high-quality statistical programming results; overseeing CRO's statistical programming deliverables; supporting preparation of clinical study reports, regulatory submissions and exploratory analyses; understanding FDA regulations affecting reporting of clinical trial data; contributing to the creation, maintenance and validation of standards for programming tools, outputs and macros; developing CRFs, edit check specifications, and data validation plans; providing review and/or author data transfer specifications for external vendor data; collaborating with internal and external functions to meet timelines; providing review and/or author SOPs and/or Work Instructions related to statistical programming practices.





Si desea conocer los requisitos para este puesto, siga leyendo para obtener toda la información relevante.

Here at Cytel we want our employees to succeed and we enable this through consistent training, development and support. Requirements include a bachelor's degree in computer science, data science, mathematics, or statistics; 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics; SAS programming expertise; extensive CDISC standards experience (SDTM, ADaM, Define.xml); experience supporting regulatory submissions and interacting with FDA/integral authorities; ability to work independently; strong communication and leadership skills. xghoner

Preferred qualifications include pharmacokinetic data and neuroscience experience; proficiency in languages/tools beyond SAS (R, Python, Java, Shiny, Markdown, Unix/Linux, git).

#J-18808-Ljbffr

📌 Senior Director, Corporate Finance & Strategy (Madrid)
🏢 Iren Group
📍 Madrid