Senior Principal Statistical Programmer (SAS + R) – Remote

Hims & Hers; Vitoria; Remote; EUR 80,000 - 125,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer for a remote role focused on SAS and R programming in a sponsor-dedicated setting within the biotech/pharma space. The role requires deep experience with SDTM/ADaM, regulatory submissions, and CRO oversight, delivering high-quality programming for clinical development programs.

You will work with minimal supervision, contribute to study reports and regulatory documents, and interact with stakeholders to ensure timely delivery while

Qualifications

• Bachelor's degree in CS, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma context.
• Strong SAS programming with SDTM/ADaM Define.xml.
• Experience with regulatory submissions and FDA/ICH.
• Ability to work independently and lead others.

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 graphs.
• Deliver high-quality SAS/R programs for clinical development programs.
• Oversee CROs' programming deliverables to meet timelines.
• 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.
• Develop CRFs, edit checks, data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external functions to meet timelines.
• Review/author SOPs for statistical programming practices.

Skills

SAS Programming

CDISC SDTM/ADaM

Regulatory Submissions

Independent Worker

Leadership

Communication Skills

Education

Bachelor's degree in Computer Science/Data Science/Math/Stats

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer for a remote role focused on SAS and R programming in a sponsor-dedicated setting within the biotech/pharma space. The role requires deep experience with SDTM/ADaM, regulatory submissions, and CRO oversight, delivering high-quality programming for clinical development programs.

You will work with minimal supervision, contribute to study reports and regulatory documents, and interact with stakeholders to ensure timely delivery while