Principal Statistical Programmer (SAS + R) - Remote

Cronoshare.Com; Arroyomolinos; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cronoshare.Com is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely on a pharmaceutical sponsor project. You will operate with autonomy, implementing SDTM/ADaM workstreams and contributing to regulatory submissions.

You will generate programs in SAS and R, supervise CRO deliverables, and ensure high quality data analyses across trials, with FDA/GCP compliance and data standards guidance.

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 descriptive and inferential statistics, 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
• Oversee CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and timely delivery
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations affecting reporting of clinical trial data 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 to ensure meeting project timelines and goals
• Provide review and

Tools

SAS

R

Job description

Cronoshare.Com is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely on a pharmaceutical sponsor project. You will operate with autonomy, implementing SDTM/ADaM workstreams and contributing to regulatory submissions.

You will generate programs in SAS and R, supervise CRO deliverables, and ensure high quality data analyses across trials, with FDA/GCP compliance and data standards guidance.