Senior Principal Statistical Programmer - SAS + R (Remote)

Oca Global; Sevilla; Remote; EUR 60,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client. The role focuses on delivering SDTM/ADaM development, SAS programming, and oversight of CRO deliverables with autonomy and ownership.

Ideal candidates have 7+ years in biostatistics programming, extensive CDISC expertise, and experience with regulatory submissions. Strong communication and leadership are essential for success in a sponsor-driven environment.

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.
• Exceptional SAS programming skills and CDISC (SDTM/ADaM) experience.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Strong communication, leadership, and ability to work independently.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and complex graphs.
• Oversee CRO programming deliverables to ensure quality and timelines.
• Prepare clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA/ICH regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Collaborate with CROs, software vendors, and clinical development partners.

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client. The role focuses on delivering SDTM/ADaM development, SAS programming, and oversight of CRO deliverables with autonomy and ownership.

Ideal candidates have 7+ years in biostatistics programming, extensive CDISC expertise, and experience with regulatory submissions. Strong communication and leadership are essential for success in a sponsor-driven environment.