Principal Statistical Programmer (SAS/R) – Remote

Helsinki Fintech Farm; Lérida; Remote; EUR 90,000 - 150,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to be embedded with a sponsor client. You will lead SAS and R programming for clinical trials, develop SDTM/ADaM datasets, and oversee CRO deliverables to ensure high-quality results.

This role emphasizes autonomy and regulatory compliance in a global context. You will contribute to clinical study reports, regulatory submissions, and exploratory analyses, while adhering to FDA guidelines for electronic submissions and

Qualifications

• Experience with SAS and R for clinical trials programming.
• Proficiency in SDTM and ADaM specifications.
• Experience overseeing CRO programming deliverables.

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 developing, validating, and maintaining SAS and/or R programs
• Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure quality and timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review

Skills

SAS

R

SDTM

ADaM

CRO oversight

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to be embedded with a sponsor client. You will lead SAS and R programming for clinical trials, develop SDTM/ADaM datasets, and oversee CRO deliverables to ensure high-quality results.

This role emphasizes autonomy and regulatory compliance in a global context. You will contribute to clinical study reports, regulatory submissions, and exploratory analyses, while adhering to FDA guidelines for electronic submissions and