Principal Statistical Programmer (SAS + R) – Remote

Hims & Hers; Las Palmas de Gran Canaria; Remote; EUR 107,000 - 133,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated team remotely.

You will implement reporting and analyses for one global pharmaceutical client, overseeing CRO programmers, and delivering high-quality data outputs across SDTM and ADaM specifications. Responsibilities span creating datasets, complex listings and graphs, contributing to regulatory submissions, and ensuring compliance with FDA/ICH guidelines.

Qualifications

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

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml.
• Develop SAS programs to produce datasets, tables, listings and graphs.
• Deliver high-quality SAS/R programming for clinical programs and analyses.
• Oversee CRO programmers to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions and DSURs.
• Follow FDA regulations and good clinical practice for submissions.
• Create and maintain standards for tools, outputs and macros.
• Develop CRF edits, data validation plans and data transfer specs.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Clinical trial data

Leadership

Independent work

FDA/ICH regulations

R

Education

Bachelor's degree in CS / Data Science / Math / Statistics

Tools

SAS

R

Define.xml

CDISC standards

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated team remotely.

You will implement reporting and analyses for one global pharmaceutical client, overseeing CRO programmers, and delivering high-quality data outputs across SDTM and ADaM specifications. Responsibilities span creating datasets, complex listings and graphs, contributing to regulatory submissions, and ensuring compliance with FDA/ICH guidelines.