Principal Statistical Programmer – SAS/R (Remote)

Ethos; Valladolid; Remote; EUR 70,000 - 120,000; Full time

Job summary

Ethos is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated role working remotely. You will implement reporting and analysis for clinical development programs, generating SDTM/ADaM outputs and collaborating with CROs to ensure high-quality deliverables.

In this role you will develop SAS and R programs, review regulatory submissions and DSURs, and ensure adherence to FDA guidelines for electronic submissions while maintaining standards for programming tools and

Qualifications

• Senior statistical programming focus
• Experience in clinical development programs
• Regulatory submission experience beneficial

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 (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

Tools

SAS

R

Job description

Ethos is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated role working remotely. You will implement reporting and analysis for clinical development programs, generating SDTM/ADaM outputs and collaborating with CROs to ensure high-quality deliverables.

In this role you will develop SAS and R programs, review regulatory submissions and DSURs, and ensure adherence to FDA guidelines for electronic submissions while maintaining standards for programming tools and