Principal Statistical Programmer (SAS & R) – Remote

Nortempo Empresa De Trabajo Temporal SL; Valladolid; Remote; EUR 116,000 - 152,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a fully remote role embedded with a global pharmaceutical client. You will lead statistical programming across SDTM/ADaM, Generate define.xml and review guides, and oversee CRO deliverables in a fast-paced environment.

You will apply extensive SAS and R expertise, ensure FDA/ICH compliance, and contribute to DR standards, SOPs, and data transfer specifications while collaborating with cross-functional teams worldwide.

Qualifications

• Minimum 7+ years as Statistical Programmer in biotech/pharma clinical development or similar
• Exceptional SAS programming skills in clinical development
• Extensive experience with CDISC SDTM/ADaM and Define.xml and FDA/ICH guidelines

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer\'s guides and define.xml files for multiple studies
• Develop SAS programs to generate datasets, listings, tables and graphs
• Deliver high-quality statistical programming outputs and maintain SAS and/or R programs
• Oversee CRO programmers to ensure timely, high-quality deliverables
• Support preparation of clinical study reports, regulatory submissions, publications and DSURs
• Understand and apply FDA regulations for electronic submissions
• Contribute to standards for programming tools, outputs and macros
• Develop CRFs, edit checks and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with CROs, software vendors, and clinical development partners to meet timelines
• Draft SOPs and Work Instructions for statistical programming practices

Skills

SAS programming

R programming

CDISC SDTM

CDISC ADaM

Define.xml

FDA/ICH regulations

CRO oversight

leadership

communication

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a fully remote role embedded with a global pharmaceutical client. You will lead statistical programming across SDTM/ADaM, Generate define.xml and review guides, and oversee CRO deliverables in a fast-paced environment.

You will apply extensive SAS and R expertise, ensure FDA/ICH compliance, and contribute to DR standards, SOPs, and data transfer specifications while collaborating with cross-functional teams worldwide.