Senior Principal Statistical Programmer – SAS + R – Remote

Responsabilidad Social Ontime S.L; Barcelona; À distance; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Cytel Inc. invites a Senior/Principal Statistical Programmer to join a sponsor-dedicated program, fully remote with a global pharmaceutical client. You will implement SDTM/ADaM, write SAS and R programs, and oversee CRO deliverables to ensure high-quality data outputs.

The role requires 7+ years in clinical programming, strong CDISC knowledge, and the ability to work independently while collaborating across teams and supporting regulatory submissions.

Qualifications

• 7+ years of experience as a Statistical Programmer in biotech/pharma clinical development.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interacting with FDA/global authorities.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewers' guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs with descriptive and inferential statistics.
• Deliver high-quality programming results and maintain SAS and/or R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of regulatory submissions, CSRs, publications, and exploratory analyses.

Connaissances

SAS

R

Python

Unix/Linux

Git

Formation

Bachelor's degree in Computer Science, Statistics, or related field

Outils

CDISC SDTM

CDISC ADaM

Define.xml

Description du poste

Cytel Inc. invites a Senior/Principal Statistical Programmer to join a sponsor-dedicated program, fully remote with a global pharmaceutical client. You will implement SDTM/ADaM, write SAS and R programs, and oversee CRO deliverables to ensure high-quality data outputs.

The role requires 7+ years in clinical programming, strong CDISC knowledge, and the ability to work independently while collaborating across teams and supporting regulatory submissions.