Principal Statistical Programmer - SAS & R (Remote)

Ethos; Islas Baleares; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a sponsor-dedicated clinical program.

You will implement reporting and analysis activities, develop SDTM/ADaM specifications, and oversee CRO programmers to ensure high-quality data deliverables. You will lead programming activities across multiple studies, contribute to CRFs and data validation plans, and ensure compliance with FDA/ICH regulations.

Qualifications

• Minimum bachelor's degree in computer science, data science, mathematics, or statistics
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics
• Exceptional SAS programming skills in clinical development environments
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations
• Regulatory submissions experience and interaction with FDA/global authorities
• Ability to work independently and lead
• Strong communication and leadership skills

Responsibilities

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

Skills

Outstanding communication

Leadership

Independent work

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

CDISC SDTM

CDISC ADaM

Define.xml

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a sponsor-dedicated clinical program.

You will implement reporting and analysis activities, develop SDTM/ADaM specifications, and oversee CRO programmers to ensure high-quality data deliverables. You will lead programming activities across multiple studies, contribute to CRFs and data validation plans, and ensure compliance with FDA/ICH regulations.