Senior Statistical Programmer (SAS/R, SDTM/ADaM) Remote

Banco Santander Sa; Madrid; Remote; EUR 70,000 - 95,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a pharma/biotech clinical development setting. You will implement SDTM/ADaM specifications, generate datasets, listings, tables, and graphs, and oversee CRO deliverables with accuracy and on time.

You will contribute to regulatory submissions, DSURs, and exploratory analyses, while ensuring FDA/GxP compliance and maintaining programming standards. Strong independence and leadership are essential.

Qualifications

• 7+ years of statistical programming in biotech/pharma development.
• Proficient in CDISC SDTM/ADaM and Define.xml.
• Experience with regulatory submissions and FDA interactions.
• Ability to work independently and lead CRO programming teams.

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 graphs
• Deliver high-quality statistical programming results and maintain SAS and/or R programs
• Oversee CROs' programming deliverables to ensure quality and timelines
• Support preparation of clinical study reports, regulatory submissions and publications
• Understand FDA regulations and guidelines for electronic submissions and GCP
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external functions to meet project timelines
• Provide SOPs and Work Instructions related to programming practices

Skills

SAS programming

R programming

CDISC standards

Clinical programming leadership

Regulatory submissions

Communication

Independent work

Education

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Tools

SAS

R

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a pharma/biotech clinical development setting. You will implement SDTM/ADaM specifications, generate datasets, listings, tables, and graphs, and oversee CRO deliverables with accuracy and on time.

You will contribute to regulatory submissions, DSURs, and exploratory analyses, while ensuring FDA/GxP compliance and maintaining programming standards. Strong independence and leadership are essential.