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 integral pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview:

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. 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. Responsibilities include: Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies Develop SAS programs which generate datasets, complex listings, tables, and complex graphs Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies Support the preparation of clinical study reports,



regulatory submissions, publications, DSUR, and exploratory analyses Understand and follow FDA regulations which affect the reporting of clinical trial data Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros 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 Collaborate with internal and external functions to ensure meeting project timelines and goals Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices Qualifications:

At a minimum bachelor's degree in computer science, data science, mathematics, or statistics; 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Biostatistics team; exceptional SAS programming skills; extensive CDISC (SDTM, ADaM, Define.xml) experience; regulatory submission experience; ability to work independently; strong communication and leadership skills. Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have the following preferred qualifications: experience with pharmacokinetic data and neuroscience; proficiency in languages/tools other than SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux and git). EEO

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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