Principal Statistical Programmer (SAS + R) - Remote

Empresa De Gestión Y Selección; León; Remote; EUR 85,000 - 130,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for remote embedded work with a global pharmaceutical client. You will lead programming activities across SDTM/ADaM, collaborate with CROs, and deliver high-quality data outputs.

The role requires 7+ years in statistical programming, expertise in CDISC standards, and experience with regulatory submissions; strong communication and independence are essential.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation.
• Experience supporting regulatory submissions and interactions with FDA or global regulatory authorities.
• Ability to work independently and Exhibit strong leadership and communication skills.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewers' guides and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and complex graphs.
• Deliver high-quality programming outputs and validate SAS and/or R programs.
• Oversee CROs' statistical programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations, GCP, and electronic submission guidelines.
• Develop and maintain programming standards, tools, outputs, and macros.
• Contribute to CRF development, edit checks, and data validation plans.
• Provide data transfer specifications for external vendors.
• Collaborate with internal/external partners to meet project goals and timelines.
• Draft SOPs and Work Instructions for programming practices.

Skills

SAS programming

Statistical programming

CDISC standards

Regulatory submissions

Independent work

Leadership

Communication

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for remote embedded work with a global pharmaceutical client. You will lead programming activities across SDTM/ADaM, collaborate with CROs, and deliver high-quality data outputs.

The role requires 7+ years in statistical programming, expertise in CDISC standards, and experience with regulatory submissions; strong communication and independence are essential.