Principal Statistical Programmer - SAS + R (Remote)

Farmacia Con Atención Al Usuario Personalizada; Alicante; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated program in a remote capacity. You will develop SDTM/ADaM specifications, write SAS and R programs, and oversee CRO programmers to deliver high-quality data outputs for clinical trials.

Ideal candidates have 7+ years in biostatistics programming, strong CDISC knowledge, and experience with regulatory submissions. You will work independently with minimal supervision and report to the Director of

Qualifications

• 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 for SDTM/ADaM and Define.xml in clinical development
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulation
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently
• Strong written and verbal communication and leadership skills

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers guide and define.xml for multiple studies
• Develop SAS programs to create datasets, complex listings, tables, and graphs
• Deliver high-quality SAS/R programming outputs for clinical programs
• Oversee CRO 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 vendor data
• Collaborate with internal/external partners to meet project goals
• Create SOPs and work instructions for programming practices

Skills

Leadership

Communication

Independence

Regulatory interaction

Education

Bachelor's degree in computer science/data science/mathematics/statistics

Tools

SAS

R

Python

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated program in a remote capacity. You will develop SDTM/ADaM specifications, write SAS and R programs, and oversee CRO programmers to deliver high-quality data outputs for clinical trials.

Ideal candidates have 7+ years in biostatistics programming, strong CDISC knowledge, and experience with regulatory submissions. You will work independently with minimal supervision and report to the Director of