Senior Principal Statistical Programmer - SAS & R (Remote)

Next Insurance, Inc.; Madrid; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will develop SDTM/ADaM specifications, datasets, and define.xmls, and lead SAS/R programming for complex tables, listings, and graphs.

You will oversee CRO programmers, ensure regulatory submissions readiness, and contribute to study reports, DSURs, and publications while adhering to GxP and FDA/ICH guidelines.

Qualifications

• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS programming skills in a clinical development environment
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently and lead CRO programming deliverables

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml for multiple studies
• Develop SAS programs to create datasets, listings, tables, and graphs
• Deliver high-quality programming results and maintain SAS and/or R programs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs
• Create and maintain standards for programming tools and macros
• Collaborate with CROs, vendors, and partners to meet project goals
• Draft SOPs and work instructions for statistical programming practices

Skills

SAS programming

R programming

CDISC standards

Regulatory submissions

Independent work

Education

Bachelor's degree in computer science/data science/mathematics/statistics

Tools

Python

Java

Unix/Linux

Git

Shiny

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will develop SDTM/ADaM specifications, datasets, and define.xmls, and lead SAS/R programming for complex tables, listings, and graphs.

You will oversee CRO programmers, ensure regulatory submissions readiness, and contribute to study reports, DSURs, and publications while adhering to GxP and FDA/ICH guidelines.