Principal Statistical Programmer - SAS/R (Remote)

Laboratorios Normon; Madrid; Hybrid; EUR 108,000 - 162,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to be fully embedded with a pharmaceutical client. You will independently manage programming activities for SDTM/ADaM deliverables, oversee CRO work, and support regulatory submissions in a remote, sponsor-dedicated setup.

The role demands extensive SAS/R experience, CDISC standards expertise, and strong communication. You will work with FDA/ICH guidelines and contribute to high-quality clinical data outputs across multiple

Qualifications

• Bachelor's degree in computer science, statistics, or related field.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development biometrics.
• Exceptional SAS programming skills and experience in clinical development environments.
• Experience with CDISC standards (SDTM/ADaM/Define.xml) and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with regulatory authorities.
• Ability to work independently and lead with strong communication.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and complex graphs.
• Deliver high-quality SAS and/or R programs tailored to clinical development program needs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• 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, outputs, and macros.
• Assist in development of CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project timelines.
• Prepare SOPs and work instructions related to statistical programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulation knowledge

Independent work

Leadership/communication

Education

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

Tools

SAS

R

Python

Unix/Linux

Define.xml

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to be fully embedded with a pharmaceutical client. You will independently manage programming activities for SDTM/ADaM deliverables, oversee CRO work, and support regulatory submissions in a remote, sponsor-dedicated setup.

The role demands extensive SAS/R experience, CDISC standards expertise, and strong communication. You will work with FDA/ICH guidelines and contribute to high-quality clinical data outputs across multiple