Arquitecto Senior De Soluciones Bancarias End-To-End

Gft Technologies Se; Córdoba; À distance; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on sponsor projects for a leading pharmaceutical client. The role emphasizes independent work, high-quality data analysis, and regulatory-compliant reporting across multiple studies.

You will develop SDTM/ADaM artifacts, write SAS and R code for complex listings and graphs, and supervise CRO programmers to ensure timely, high-quality outputs. Regulatory familiarity and adherence to GxP guidelines are required.

Qualifications

• Experience with SAS programming for clinical data and reports.
• Proficiency in R for statistical analyses and data visualization.
• Knowledge of CDISC SDTM/ADaM standards and regulatory expectations.

Responsabilités

• Generate SDTM/ADaM specifications, datasets, and define.xml files for studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality programming results and maintain SAS/R code for trials.
• Oversee CRO programmers to ensure timely, compliant deliverables.
• Support preparation of study reports, regulatory submissions, and analyses.
• Adhere to FDA/regulatory guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Assist in CRF development, edit checks, and data validation plans.

Connaissances

SAS

R

SDTM

ADaM

Clinical standards

Description du poste

Senior/Principal Statistical Programmer SAS + R (Remote)

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview: This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

As a Principal Statistical Programmer, your responsibilities will include:

• 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