Senior/Principal Statistical Programmer - SAS & R (Remote)

Edwards Lifesciences Gruppe; Valencia; Remote; EUR 70,000 - 105,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on clinical development programs. You will be dedicated to one or more global pharmaceutical clients and lead programming activities with autonomy and ownership.

You will generate SDTM/ADaM specifications, develop SAS and R programs, and oversee CRO outputs to ensure timely, high-quality data for regulatory submissions and reports.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years as Statistical Programmer in Biotech/Pharma clinical development or similar team.
• SAS programming skills with experience in CDISC standards (SDTM/ADaM/Define.xml).
• Experience supporting regulatory submissions and interactions with FDA/regulatory authorities.
• Independent work capability with strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and Define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver SAS and/or R programs for clinical development programs and ensure quality.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of CSRs, regulatory submissions, publications, DSUR and explorations.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards development for programming tools and outputs.
• Develop CRFs, edit check specs and data validation plans.
• Provide data transfer specifications for external vendors.
• Collaborate with internal and external partners to meet project goals.
• Provide SOPs and work instructions for programming practices.

Skills

SAS

R

Statistical programming

Independent worker

Leadership

Education

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

Tools

CDISC SDTM

CDISC ADaM

Define.xml

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on clinical development programs. You will be dedicated to one or more global pharmaceutical clients and lead programming activities with autonomy and ownership.

You will generate SDTM/ADaM specifications, develop SAS and R programs, and oversee CRO outputs to ensure timely, high-quality data for regulatory submissions and reports.