Principal Statistical Programmer (SAS + R) — Remote

PCI TRGR Penn Pharmaceutical Services Ltd; León; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer with SAS and R expertise for a remote role. You will work within sponsor programs, oversee CRO deliverables, and ensure high-quality data summaries for clinical trials.

You will implement reporting and analysis activities, while ensuring compliance with GCP and regulatory guidelines. This role demands extensive biotech experience and leadership in statistical programming across therapeutic areas.

Qualifications

• Extensive experience in clinical development programming.
• Ability to deliver SDTM/ADaM specs and define.xml files.
• Familiarity with FDA GCP and electronic submission guidelines.

Responsibilities

• Generate SDTM and ADaM specs, datasets, reviewer’s guide, and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality results with SAS and/or R tailored to program needs.
• Oversee CROs' statistical programming deliverables across studies within timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Adhere to FDA regulations and good clinical practice for submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Contribute to CRF development, edit checks, and data validation plans.
• Provide review and guidance on programming outputs.

Skills

SAS programming

R programming

SDTM/ADaM

Education

Biostatistics or related field (advanced degree)

Tools

CRO oversight

Job description

Cytel is seeking a Senior/Principal Statistical Programmer with SAS and R expertise for a remote role. You will work within sponsor programs, oversee CRO deliverables, and ensure high-quality data summaries for clinical trials.

You will implement reporting and analysis activities, while ensuring compliance with GCP and regulatory guidelines. This role demands extensive biotech experience and leadership in statistical programming across therapeutic areas.