Lead Remote Statistical Programmer (SAS + R)

DutchTechX; Lérida; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work on sponsor-driven clinical programs across therapeutic areas. You will implement reporting and analysis activities for sponsor trials and oversee CRO programmers to ensure high-quality deliverables.

You will develop SDTM/ADaM datasets, specify define.xml, and produce complex tables, listings, and graphs, using SAS and R, while adhering to FDA/ICH guidelines and clinical submission expectations.

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 and implementation experience in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with authorities.
• Ability to work independently with strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and Define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and complex graphs.
• Deliver high-quality statistical programming results using SAS and/or R.
• Oversee CROs' programming deliverables to meet timelines and quality.
• Support preparation of CSRs, regulatory submissions, publications, and DSURs.
• 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.

Skills

SAS programming

CDISC standards (SDTM/ADaM/Define.xml)

Regulatory submissions

Leadership/independence

Communication skills

Education

Bachelor's degree in Computer Science/Data Science/Mathematics/Statistics

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work on sponsor-driven clinical programs across therapeutic areas. You will implement reporting and analysis activities for sponsor trials and oversee CRO programmers to ensure high-quality deliverables.

You will develop SDTM/ADaM datasets, specify define.xml, and produce complex tables, listings, and graphs, using SAS and R, while adhering to FDA/ICH guidelines and clinical submission expectations.