Principal Statistical Programmer

Job Description

Seeking a Principal Statistical Programmer to contribute to pharmaceutical clinical development. The role involves generating SDTM and ADaM datasets, creating SAS programs for tables and graphs, and ensuring high-quality statistical programming results. Key responsibilities include overseeing CRO deliverables, supporting clinical study reports, and adhering to FDA regulations. The position also includes contributing to the development of programming standards and collaborating with internal and external teams to meet project timelines and goals.

Qualifications

1. Bachelor's degree in computer science, data science, mathematics, or statistics. 2. 7+ years of experience as a Statistical Programmer in a Biotech/Pharma Clinical Development Biometrics Team. 3. Expertise in SAS programming and implementation of statistical programming procedures. 4. Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, and FDA/ICH regulations. 5. Experience supporting regulatory submissions and interacting with regulatory authorities. 6. Ability to work independently. 7. Strong communication and leadership skills.

Benefits

- Working fully embedded within one of our pharmaceutical clients - Support of Cytel right behind you - Commitment to developing staff - Significant professional growth opportunities