Principal Statistical Programmer - SAS + R (Remote)

Hims & Hers; Gijón; Remote; EUR 98,000 - 125,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to join our sponsor-dedicated team, working remotely with a leading pharmaceutical client.

You will implement reporting and analysis activities across multiple studies, mentor CRO programmers, and ensure high-quality data outputs in line with FDA/ICH guidelines. You will develop SDTM/ADaM specifications, write SAS programs for datasets, listings, tables and graphs, and contribute to CRF/validation plans while collaborating

Qualifications

• At a minimum Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in developing statistical programming procedures.
• Extensive applied experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA/global regulatory authorities.
• Must be able to work independently.
• Outstanding communication skills (written and verbal) and strong leadership skills.
• Nice to have: experience with pharmacokinetic data and neuroscience; proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux and Git.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs to generate datasets, complex listings, tables and graphs
• Deliver high-quality statistical programming results using SAS and/or R
• Oversee CROs' programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and analyses
• Comply with FDA regulations and guidelines for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external functions to meet timelines and goals
• Provide review/author SOPs and Work Instructions for statistical programming practices

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent work

Collaboration with CROs

Statistical programming

Education

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Tools

R

Python

Unix/Linux

Git

Shiny

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to join our sponsor-dedicated team, working remotely with a leading pharmaceutical client.

You will implement reporting and analysis activities across multiple studies, mentor CRO programmers, and ensure high-quality data outputs in line with FDA/ICH guidelines. You will develop SDTM/ADaM specifications, write SAS programs for datasets, listings, tables and graphs, and contribute to CRF/validation plans while collaborating