Principal Statistical Programmer: SAS + R (Remote)

Intress; Inca; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a sponsor-dedicated program within a pharmaceutical client. You will implement reporting/analysis activities, supervise CRO programmers, and ensure high-quality data outputs across multiple studies.

The role requires extensive SAS experience, CDISC standards expertise, and strong independence with leadership capabilities in a global setting.

Qualifikationen

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in SDTM, ADaM, and Define.xml.
• Experience supporting regulatory submissions and interaction with FDA or global authorities.
• Must be able to work independently and show strong leadership and communication skills.

Aufgaben

• Generate SDTM, ADaM specs, datasets, reviewers' guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results using SAS and/or R.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSUR.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards development for programming tools and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal and external partners to meet timelines.
• Prepare SOPs and Work Instructions for programming practices.

Kenntnisse

SAS programming

Leadership

Communication skills

Independent work

Ausbildung

Bachelor's degree in computer science or data-related field

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a sponsor-dedicated program within a pharmaceutical client. You will implement reporting/analysis activities, supervise CRO programmers, and ensure high-quality data outputs across multiple studies.

The role requires extensive SAS experience, CDISC standards expertise, and strong independence with leadership capabilities in a global setting.