Principal Statistical Programmer (SAS + R) - Remote

Colegio Oficial De Farmacéuticos De Cádiz; Jerez de la Frontera; À distance; EUR 99 000 - 134 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a remote role dedicated to one pharmaceutical client.

You will lead programming activities across SDTM/ADaM specifications, create define.xml and reviewers’ guides, and oversee CRO deliverables to ensure timely, high-quality data outputs for regulatory submissions. The role requires expert SAS programming, CDISC standards proficiency, and the ability to work independently in a global, sponsor-dedicated environment.

Qualifications

• Bachelor's degree in a related field; 7+ years as Statistical Programmer in Biotech/Pharma
• Exceptional SAS programming skills in a clinical development environment
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently and lead
• Strong written and verbal communication skills

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies
• Develop SAS programs to produce datasets, listings, tables and graphs
• Deliver high-quality programming results; maintain SAS and/or R programs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions and publications
• Follow GCP and regulatory guidelines for electronic submissions
• Contribute to standards for programming tools, outputs and macros
• Assist in development of CRFs, edit checks, and data validation plans
• Review and/or author data transfer specifications for external vendor data
• Collaborate with CROs, vendors and clinical development partners to meet timelines
• Prepare and review SOPs and Work Instructions for statistical programming practices

Connaissances

SAS programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

FDA/ICH regulations

Independent work

Leadership

Communication skills

Formation

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

Outils

R

Python

Unix/Linux

Git

Shiny

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a remote role dedicated to one pharmaceutical client.

You will lead programming activities across SDTM/ADaM specifications, create define.xml and reviewers’ guides, and oversee CRO deliverables to ensure timely, high-quality data outputs for regulatory submissions. The role requires expert SAS programming, CDISC standards proficiency, and the ability to work independently in a global, sponsor-dedicated environment.