Principal Statistical Programmer - SAS & R (Remote)

Innovasur; Jaén; Remote; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with one of our global pharmaceutical clients. You will implement all reporting and analysis activities for Sponsor trials, guide CROs, and ensure high-quality data outputs in SDTM/ADaM frameworks.

You will lead SAS and R programming efforts across multiple studies, contribute to CSRs and regulatory submissions, and ensure compliance with GCP and FDA electronic submission guidelines.

Qualifikationen

• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
• Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment

Aufgaben

• 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
• Oversee CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet 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 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/or author SOPs and/or Work Instructions related to statistical programming practices

Kenntnisse

SAS programming

R programming

Biostatistics knowledge

Clinical trial programming

Ausbildung

Bachelor's degree in Computer Science, Data Science, Mathematics or Statistics

Tools

SAS

R

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with one of our global pharmaceutical clients. You will implement all reporting and analysis activities for Sponsor trials, guide CROs, and ensure high-quality data outputs in SDTM/ADaM frameworks.

You will lead SAS and R programming efforts across multiple studies, contribute to CSRs and regulatory submissions, and ensure compliance with GCP and FDA electronic submission guidelines.