Principal Statistical Programmer (SAS + R) — Remote

Fundacion I+D De Software Libre; Madrid; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a leading pharmaceutical client. The role involves independent work under minimal supervision, delivering SDTM/ADaM specifications, datasets, and define.xmls across multiple studies, and supervising CRO programming deliverables.

You will develop SAS programs to produce complex tables, listings, and graphs, support regulatory submissions, and contribute to study reports and DSURs.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in SAS procedures and processes in a clinical development environment.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml), medical terminology, trials methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA and global regulatory authorities.
• Ability to work independently and demonstrate strong leadership and communication skills.

Responsibilities

• + Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• + Develop SAS programs to generate datasets, listings, tables and complex graphs
• + Deliver high-quality statistical programming results including SAS and/or R programs
• + Oversee CRO's statistical programming deliverables to meet timelines
• + Support preparation of clinical study reports, regulatory submissions, publications, and DSURs
• + Understand and follow FDA regulations; ensure compliant submissions and data handling
• + Create, maintain, and validate standards for programming tools, outputs, and macros
• + Collaborate with CROs, vendors and internal teams to meet project goals
• + Provide SOPs/Work Instructions related to statistical programming practices

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Communication skills

Independent work

Education

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Tools

SAS

R

Python

Git

Unix/Linux

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a leading pharmaceutical client. The role involves independent work under minimal supervision, delivering SDTM/ADaM specifications, datasets, and define.xmls across multiple studies, and supervising CRO programming deliverables.

You will develop SAS programs to produce complex tables, listings, and graphs, support regulatory submissions, and contribute to study reports and DSURs.