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 programsto generate datasets, complex listings, tables and graphs;
delivering high-qualitystatistical 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/orauthor data transfer specifications for external vendor data;
collaborating with internal and external functions to meet timelines;




providing review and/orauthor 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/integral 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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