Principal Statistical Programmer (Remote, EMEA) — SAS + R

Seeq Corporation; Huelva; A distancia; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to be fully embedded with a pharmaceutical client. You will drive SDTM/ADaM specifications, develop SAS and R programs, and oversee CRO deliverables across multiple studies while ensuring regulatory compliance and data integrity.

The role emphasizes independence, high-quality analytics, and collaboration with statisticians and data managers in a remote setting.

Responsabilidades

• 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
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and

Conocimientos

SAS programming

R programming

SDTM/ADaM specs

Clinical trial programming

CRO oversight

Regulatory compliance

Herramientas

define.xml standards

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to be fully embedded with a pharmaceutical client. You will drive SDTM/ADaM specifications, develop SAS and R programs, and oversee CRO deliverables across multiple studies while ensuring regulatory compliance and data integrity.

The role emphasizes independence, high-quality analytics, and collaboration with statisticians and data managers in a remote setting.