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 a global pharmaceutical company that is driving the next generation of patient treatment, empowering individuals to work with autonomy and ownership. This position reports to the Director, Biostatistics and Programming in the FSP Services business unit at Cytel.
The Principal Statistical Programmer works independently with minimal supervision, tracks progress, and provides expert technical support to team members. We seek a highly experienced senior statistical programmer to work across various therapeutic areas, oversee CRO programmers, and ensure high-quality, consistent data summaries for clinical development programs.
Your responsibilities will include:
1. Generating SDTM, ADaM specifications, datasets, reviewer's guides, and define.xml files for multiple studies.
2. Developing SAS programs to generate datasets, listings, tables, and complex graphs.
3. Delivering high-quality statistical programming results, including developing, validating, and maintaining SAS and/or R programs tailored to project needs.
4. Overseeing CRO's programming deliverables to ensure quality and timeliness.
5. Supporting clinical study reports, regulatory submissions, publications, and exploratory analyses.
6. Understanding and adhering to FDA regulations affecting clinical trial data reporting.
7. Contributing to the creation, maintenance, and validation of programming standards and macros.
8. Participating in the development of CRFs, edit check specifications, and data validation plans.
9. Reviewing and authoring data transfer specifications for external data vendors.
10. Collaborating with internal and external partners to meet project timelines and goals.
11. Reviewing and authoring SOPs and Work Instructions related to statistical programming.
To succeed, you should have:
* A minimum of a bachelor's degree in computer science, data science, mathematics, or statistics.
* At least 7 years of experience as a Statistical Programmer supporting drug development or related fields.
* Exceptional SAS programming skills and experience with statistical procedures in a clinical environment.
* Extensive knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations.
* Experience supporting regulatory submissions and interacting with regulatory authorities.
* The ability to work independently.
* Outstanding communication and leadership skills.
Preferred qualifications include prior experience with pharmacokinetic data, neuroscience, and proficiency in additional languages or tools such as R, Python, Java, Shiny, Markdown, Unix/Linux, and git.
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