Principal Statistical Programmer - Functional Service Provider (FSP) Engagements

Are you ready to take your statistical programming career to the next level? Join us as a Principal Statistical Programmer where you'll play a key technical and strategic role across multiple clinical studies and post-marketing projects. You'll work hands-on with advanced analytical techniques, lead programming efforts, and collaborate with cross-functional industry leaders to deliver high-quality results that support patient safety, drug efficacy, and regulatory success.

What You'll Do

• Lead Statistical Programming: Be the main programming expert for assigned studies, working closely with sponsors and internal teams to drive project success.

• Develop Reliable Analyses: Create and validate SAS programs for analysis datasets (ADaM), tables, listings, and figures that underpin clinical study reports, interim analyses, and exploratory data reviews.

• Champion Quality and Compliance: Review and oversee statistical deliverables from external partners to ensure accuracy and regulatory alignment.

• Shape Regulatory Submissions: Prepare submission-ready documentation (define.xml, annotated CRFs, Reviewer's Guides), and collaborate on pooled analyses for integrated safety & efficacy summaries.

• Collaborate and Communicate: Work alongside biostatistics, data management, and medical writing teams to meet project timelines and deliverables.

• Promote Process Improvement: Streamline and automate workflows using tools like R, Python, or metadata frameworks.

• Mentor and Inspire: Support junior programmers, fostering growth in statistical programming and data analytics.

• Ensure Audit Readiness: Maintain top-quality documentation and compliance with industry standards and best practices.

Who You Are

Do you have experience in XML?, Do you have a Master's degree?, * Experienced Programmer: Master's degree (7+ years) or Bachelor's (9+ years) in Statistics, Computer Science, or a related field, with hands-on experience in clinical trial statistical programming.

• CDISC Expert: Deep knowledge of SDTM and ADaM standards and submission processes.

• Analytical Leader: Proven ability to handle ad-hoc and exploratory analyses, and support publication and regulatory responses.

• Collaborator: Strong communication skills and experience leading projects and managing deliverables from external providers.

• Tech-Savvy: Experience with Pinnacle 21, Define.xml, and data visualization platforms (Spotfire, R Shiny) is a plus.

• Innovator: Familiarity with R or Python for automation and statistical programming is highly desirable.