Senior Principal Statistical Programmer (Remote) - SAS + R

Farmacias Trébol S.L.; Colmenar Viejo; À distance; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated program, working fully embedded with one of our pharmaceutical clients.

You will lead programming activities across SDTM/ADaM, define.xml and regulatory deliverables, with minimal supervision and strong ownership. The role requires 7+ years of experience, excellent SAS skills, CDISC expertise, and the ability to oversee CROs and collaborate with cross-functional teams.

Qualifications

• 7+ years of experience as a Statistical Programmer on Biotech/Pharma teams.
• Expert in SAS programming and clinical data analysis.
• Extensive CDISC SDTM/ADaM/Define.xml experience and FDA/ICH knowledge.
• Experience supporting regulatory submissions and interactions with regulators.
• Ability to work independently and lead project deliverables.

Responsabilités

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml for multiple studies
• Develop SAS programs for datasets, listings, tables, graphs
• Deliver high-quality programming results; validate and maintain SAS/R programs
• Oversee CRO programming deliverables and timelines
• Support clinical study reports, regulatory submissions, DSURs, explorations
• Collaborate with CROs, vendors, and clinical teams to meet timelines
• Develop and maintain programming standards, tools, macros
• Review data transfer specifications for external data
• Contribute SOPs and work instructions for programming practices
• Follow FDA regulations and GCP for electronic submissions

Connaissances

SAS programming

CDISC standards

Regulatory submissions

Communication & leadership

Independent work

Formation

Bachelor's degree in CS/Data Science/Math/Statistics

Outils

SAS

R

Python

Unix/Linux

Git

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated program, working fully embedded with one of our pharmaceutical clients.

You will lead programming activities across SDTM/ADaM, define.xml and regulatory deliverables, with minimal supervision and strong ownership. The role requires 7+ years of experience, excellent SAS skills, CDISC expertise, and the ability to oversee CROs and collaborate with cross-functional teams.