Senior Statistical Programmer (Remote) - SAS + R

Jobgether; La Coruña; À distance; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Jobgether is seeking an experienced Principal Statistical Programmer to work remotely for a sponsor-dedicated program with embedded collaboration to a global pharmaceutical client. The role involves independently leading programming activities, SDTM/ADaM development, and overseeing CRO deliverables while ensuring quality and regulatory compliance.

The candidate will develop SAS and R programs for datasets, listings, tables, and graphs, contribute to CRF development, data validation plans, and

Qualifications

• Experience leading statistical programming in clinical development.
• Ability to oversee CRO programmers and ensure high-quality data summaries.
• Experience with SAS and R and SDTM/ADaM specifications.
• Knowledge of FDA regulations and electronic submissions.

Responsabilités

• 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

Connaissances

SAS

R

SDTM/ADaM

Statistical programming

Description du poste

Jobgether is seeking an experienced Principal Statistical Programmer to work remotely for a sponsor-dedicated program with embedded collaboration to a global pharmaceutical client. The role involves independently leading programming activities, SDTM/ADaM development, and overseeing CRO deliverables while ensuring quality and regulatory compliance.

The candidate will develop SAS and R programs for datasets, listings, tables, and graphs, contribute to CRF development, data validation plans, and