Principal Statistical Programmer — SAS + R (Remote)

Colegio Oficial De Farmacéuticos De Cádiz; Badajoz; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work with a sponsor in a dedicated role. You will implement reporting and analysis activities for clinical trials, generate CDISC specifications, and oversee CRO programming to ensure high quality and timely delivery.

You will use SAS (and R) to develop datasets, listings, tables, and complex graphs, while adhering to FDA/ICH guidelines. Strong independence, leadership, and communication are essential in this role.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics (preferred)
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics teams
• Exceptional SAS programming skills and experience in clinical development environments
• Extensive experience with CDISC SDTM/ADaM/Define.xml, medical terminology, FDA/ICH regulations
• 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, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to create datasets, listings, tables and graphs
• Deliver high-quality SAS/R programs tailored to clinical programs
• Oversee CRO programming deliverables to meet timelines
• Support clinical study reports, regulatory submissions, publications and DSURs
• Contribute to standards for programming tools, outputs, and macros
• Collaborate with CROs, vendors and partners to meet timelines and goals
• Draft SOPs and Work Instructions related to statistical programming practices

Skills

Communication skills

Leadership

Independent work

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work with a sponsor in a dedicated role. You will implement reporting and analysis activities for clinical trials, generate CDISC specifications, and oversee CRO programming to ensure high quality and timely delivery.

You will use SAS (and R) to develop datasets, listings, tables, and complex graphs, while adhering to FDA/ICH guidelines. Strong independence, leadership, and communication are essential in this role.