Principal Statistical Programmer (SAS+R) - Remote

Airbus; Cáceres; Remote; EUR 80,000 - 116,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated program with a pharmaceutical client, supported by Cytel.

The role requires independence, strong SAS programming, and expertise in CDISC standards for clinical trials. You will generate SDTM/ADaM specifications and datasets, oversee CRO programmers, and contribute to regulatory submissions and study reports, while adhering to GCP and FDA/ICH guidelines.

Qualifications

• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Biometrics teams
• Exceptional SAS programming skills in a clinical development environment
• Extensive experience with CDISC SDTM/ADaM/Define.xml and FDA/ICH regulation
• Experience supporting regulatory submissions and interactions with regulatory authorities
• Ability to work independently and lead CRO programming deliverables

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to generate datasets, listings, tables and graphs
• Deliver high-quality statistical programming results and maintain SAS/R programs for clinical development
• Oversee CRO programmers to ensure high-quality deliverables within timelines
• Support preparation of clinical study reports, regulatory submissions and exploratory analyses
• Follow FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specifications, and data validation plans
• Provide data transfer specifications for external vendor data
• Collaborate with CROs, vendors, and clinical partners to meet timelines
• Prepare SOPs and work instructions for statistical programming practices

Skills

SAS programming

CDISC standards

R programming

Regulatory submissions

Leadership

Independent work

Education

Bachelor’s degree in CS/Math/Stats

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated program with a pharmaceutical client, supported by Cytel.

The role requires independence, strong SAS programming, and expertise in CDISC standards for clinical trials. You will generate SDTM/ADaM specifications and datasets, oversee CRO programmers, and contribute to regulatory submissions and study reports, while adhering to GCP and FDA/ICH guidelines.