Remote Principal Statistical Programmer - FSP

Cytel; Olympia (WA); Remote; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to join a sponsor-dedicated program in the US, embedded with a leading pharmaceutical client. You will lead SAS development for SDTM/ADaM, reviewer’s guides, define.xml, and complex listings and graphs, while overseeing CRO deliverables and ensuring regulatory-compliant data outputs.

You will work with a senior Biostatistics group, contribute to clinical study reports and submissions, and apply CDISC standards and FDA/ICH guidelines to maintain

Qualifications

• Bachelor's degree or higher in a quantitative field (CS, statistics, data science)
• 7+ years of experience as a Statistical Programmer in biotech/pharma
• Exceptional SAS programming skills and CDISC SDTM/ADaM experience
• Experience interacting with regulatory authorities or submitting to FDA/ICH

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies
• Develop SAS programs for datasets, listings, tables, and graphs
• Lead CRO oversight for programming deliverables and timelines
• Support regulatory submissions, clinical study reports, and DSURs
• Follow FDA regulations and good clinical practice for electronic submissions
• Contribute to standards for programming tools, outputs and macros
• Draft CRFs, edit checks, and data validation plans
• Review data transfer specifications for external vendors

Skills

SAS programming

Leadership

Communication skills

Education

Bachelor's degree in CS/Statistics/Data Science

Tools

R

Python

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to join a sponsor-dedicated program in the US, embedded with a leading pharmaceutical client. You will lead SAS development for SDTM/ADaM, reviewer’s guides, define.xml, and complex listings and graphs, while overseeing CRO deliverables and ensuring regulatory-compliant data outputs.

You will work with a senior Biostatistics group, contribute to clinical study reports and submissions, and apply CDISC standards and FDA/ICH guidelines to maintain