Principal Statistical Programmer (SAS + R) - Remote

Jobgether; Badajoz; Remote; EUR 70,000 - 90,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a pharma client ecosystem. You will lead statistical programming across CDISC SDTM/ADaM standards, develop and validate SAS and R programs, and oversee CRO deliverables to ensure timely, high-quality data presentations.

You will contribute to CSR preparation, regulatory submissions, and exploratory analyses while adhering to GCP and FDA guidelines.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Biometric Teams.
• Exceptional SAS programming skills and experience in clinical development.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml).

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 for clinical development programs.
• Oversee CROs' programming deliverables to meet timelines and quality expectations.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and analyses.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Participate in CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specs for external data.
• Collaborate with CROs and vendors to meet project goals.
• Prepare SOPs/Work Instructions related to statistical programming.

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml experience

Clinical data analysis

Education

Bachelor's degree in Computer Science

Bachelor's degree in Data Science

Bachelor's degree in Mathematics

Bachelor's degree in Statistics

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a pharma client ecosystem. You will lead statistical programming across CDISC SDTM/ADaM standards, develop and validate SAS and R programs, and oversee CRO deliverables to ensure timely, high-quality data presentations.

You will contribute to CSR preparation, regulatory submissions, and exploratory analyses while adhering to GCP and FDA guidelines.