Remote Principal Statistical Programmer, SAS/R

Ingenio Ec; Almería; Remote; EUR 85,000 - 134,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on clinical development programs across therapeutic areas. You will implement reporting and analysis activities, coordinate with CROs, and ensure high-quality, timely outputs for regulatory submissions.

The role involves developing SDTM/ADaM specifications, writing SAS and R programs, and supporting CSR preparation under FDA guidelines. This is a sponsor-dedicated position with global client engagement.

Qualifications

• Extensive experience in clinical statistical programming for pharmaceutical trials.
• Ability to deliver SDTM/ADaM specifications and define.xml for multiple studies.
• Experience supervising CRO programmers and ensuring timely, high-quality deliverables.
• Knowledge of FDA regulations, GCP, and electronic submission guidelines.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml for studies.
• Develop SAS programs to produce datasets, listings, tables, and graphs.
• Deliver high-quality programming outputs using SAS and R.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of CSRs, regulatory submissions, publications, and DSURs.
• Understand and apply FDA regulations affecting reporting of clinical data.

Skills

SAS programming

R programming

SDTM

ADaM

CRO oversight

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on clinical development programs across therapeutic areas. You will implement reporting and analysis activities, coordinate with CROs, and ensure high-quality, timely outputs for regulatory submissions.

The role involves developing SDTM/ADaM specifications, writing SAS and R programs, and supporting CSR preparation under FDA guidelines. This is a sponsor-dedicated position with global client engagement.