Principal Statistical Programmer (SAS + R) - Remote

Stem-Force; Morcín; A distancia; EUR 80.000 - 116.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-dedicated pharmaceutical projects. You will implement all reporting and analysis activities for sponsor trials, oversee CRO deliverables, and develop SAS and R programs for datasets, tables, listings, and graphs across therapeutic areas.

You will contribute to study reports, regulatory submissions, and exploratory analyses while adhering to FDA guidelines and industry standards.

Formación

• Experience in programming for clinical trials.
• Ability to develop SDTM/ADaM specifications and datasets.
• Experience leading CRO programming deliverables.

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, 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.
• 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

Conocimientos

SAS

R

SDTM

ADaM

Clinical programming

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-dedicated pharmaceutical projects. You will implement all reporting and analysis activities for sponsor trials, oversee CRO deliverables, and develop SAS and R programs for datasets, tables, listings, and graphs across therapeutic areas.

You will contribute to study reports, regulatory submissions, and exploratory analyses while adhering to FDA guidelines and industry standards.