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.

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/general authorities; ability to work independently; strong communication and leadership skills.

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

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