Principal Statistical Programmer (Remote) SAS & R Expert

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

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated program within one of our pharmaceutical clients, supporting data analysis and reporting with autonomy and ownership. The role focuses on SDTM/ADaM generation, SAS and R programming, and oversight of CRO deliverables to ensure high-quality, timely submissions in a regulated environment.

You will work in a fast-paced biostatistics team, contribute to study reports and regulatory documents, and interact

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in development and implementation of statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, FDA/ICH regulation.
• Experience supporting regulatory submissions and interaction with FDA and/or global regulatory authorities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables and graphs
• Deliver high-quality statistical programming results including SAS and/or R programs
• Oversee CRO's statistical programming deliverables to ensure high-quality and timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and exploratory analyses
• Understand and follow FDA regulations affecting reporting of clinical trial data
• Contribute to creation, maintenance, documentation, and validation of standards for programming tools and macros
• Develop CRFs, edit check specifications, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external functions to meet project timelines
• Provide review/author SOPs and/or Work Instructions related to statistical programming practices

Skills

SAS programming

CDISC SDTM/ADaM

Communication skills

Leadership

Independent work

R/Python knowledge

Education

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

Tools

SAS

R

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated program within one of our pharmaceutical clients, supporting data analysis and reporting with autonomy and ownership. The role focuses on SDTM/ADaM generation, SAS and R programming, and oversight of CRO deliverables to ensure high-quality, timely submissions in a regulated environment.

You will work in a fast-paced biostatistics team, contribute to study reports and regulatory documents, and interact