Principal Statistical Programmer (SAS + R) – Remote

Vicedo Martí S.L.; Alicante; Remote; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to work embedded with a pharmaceutical client. You will operate with minimal supervision, lead programming activities, and ensure high-quality data outputs across SDTM/ADaM, listings, tables and graphs.

You will develop and validate SAS and R programs, oversee CRO deliverables, contribute to clinical study reports and regulatory submissions, and ensure compliance with FDA guidelines.

Qualifikationen

• Extensive experience in statistical programming for clinical trials.
• Ability to work independently with minimal supervision and manage CROs.
• Experience delivering SDTM/ADaM specifications and reports.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
• Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified 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. This includes good clinical practice and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans

Kenntnisse

Statistical programming

Clinical trials

Independent worker

Tools

SAS

R

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to work embedded with a pharmaceutical client. You will operate with minimal supervision, lead programming activities, and ensure high-quality data outputs across SDTM/ADaM, listings, tables and graphs.

You will develop and validate SAS and R programs, oversee CRO deliverables, contribute to clinical study reports and regulatory submissions, and ensure compliance with FDA guidelines.