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;
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) #LI-KO1 Cytel Inc. is an Equal Employment / Affirmative Action Employer.

📌 Senior Project Manager, Early Development (Emea) (Murcia)
🏢 ThermoFisher Scientific
📍 Murcia