Principal Statistical Programmer (SAS + R) - Remote

Deel; Badajoz; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-dedicated role, embedded with a pharmaceutical client. You will implement reporting and analysis activities across multiple studies, with minimal supervision and leadership responsibilities.

Responsibilities include generating SDTM/ADaM specifications, developing SAS programs for datasets, listings, tables and graphs, overseeing CRO deliverables, and supporting regulatory submissions.

Qualifications

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team.
• Experience supporting drug development, medical device development, or intervention studies.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and regulatory requirements.
• Exceptional SAS programming skills and ability to deliver high-quality results in a clinical setting.
• Experience supporting regulatory submissions and interactions with FDA/ICH.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, review's guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs.
• Oversee CRO deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Review/author data transfer specifications for external data.
• Collaborate with internal and external partners to meet timelines.
• Draft SOPs and Work Instructions related to statistical programming.

Skills

SAS programming

CDISC standards

Regulatory submissions (FDA/ICH)

Communication

Leadership

Independent work

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-dedicated role, embedded with a pharmaceutical client. You will implement reporting and analysis activities across multiple studies, with minimal supervision and leadership responsibilities.

Responsibilities include generating SDTM/ADaM specifications, developing SAS programs for datasets, listings, tables and graphs, overseeing CRO deliverables, and supporting regulatory submissions.