Principal Statistical Programmer (SAS/R) - Remote

Amazon Web Services (Aws); Madrid; Remote; EUR 65,000 - 90,000; Full time

Job summary

Cytel seeks a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, supported by Cytel. You will lead SAS/R programming, generate SDTM/ADaM datasets, and oversee CRO deliverables to ensure high quality, compliant data for regulatory submissions.

You will collaborate with statisticians and cross-functional teams, drive programming standards, and contribute to study reports and publications, while adhering to FDA/ICH regulations and GCP guidelines.

Qualifications

• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team.
• Expertise in SDTM/ADaM and Define.xml.
• Experience supporting regulatory submissions with FDA/global authorities.
• Strong communication and leadership abilities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, listings, tables, and graphs
• Deliver SAS and/or R programs for clinical development programs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications
• Understand FDA regulations affecting reporting of trial data
• Contribute to creation and validation of programming standards
• Develop CRFs, edit checks, and data validation plans
• Provide data transfer specifications for external vendors
• Collaborate with CROs, vendors, and partners
• Provide SOPs and work instructions related to statistical programming

Skills

SAS programming

CDISC SDTM/ADaM/Define.xml

FDA/ICH regulations

R

Python

Unix/Linux

Git

Leadership

Communication skills

Education

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

Job description

Cytel seeks a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, supported by Cytel. You will lead SAS/R programming, generate SDTM/ADaM datasets, and oversee CRO deliverables to ensure high quality, compliant data for regulatory submissions.

You will collaborate with statisticians and cross-functional teams, drive programming standards, and contribute to study reports and publications, while adhering to FDA/ICH regulations and GCP guidelines.