Principal Statistical Programmer (Remote) - SAS & R

Hims & Hers; Tarragona; Remote; EUR 70,000 - 90,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated program with a global pharmaceutical client. You will lead SAS and R programming, SDTM/ADaM specifications, and ensure high-quality data analyses and documentation.

The role requires independent work, strong regulatory familiarity with FDA/ICH, and engagement in submissions, study reports, DSURs, and data-validation plans while collaborating with CROs and internal teams.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills and experience.
• CDISC SDTM/ADaM and Define.xml knowledge.
• Experience supporting regulatory submissions and interacting with FDA/ICH.
• Ability to work independently and lead.
• Strong written and verbal communication and leadership.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R programs and validate them.
• Oversee CRO programming deliverables and timelines.
• Support preparation of clinical study reports and regulatory submissions (DSUR, publications).
• Adhere to FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendors.
• Collaborate with CROs, software vendors, and partners to meet goals.
• Review and write SOPs and work instructions for programming.

Skills

SAS programming

CDISC SDTM/ADaM

R programming

FDA/ICH regulations

Clinical trials

Leadership

Communication

Education

Bachelor's degree

Statistics background

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated program with a global pharmaceutical client. You will lead SAS and R programming, SDTM/ADaM specifications, and ensure high-quality data analyses and documentation.

The role requires independent work, strong regulatory familiarity with FDA/ICH, and engagement in submissions, study reports, DSURs, and data-validation plans while collaborating with CROs and internal teams.