Ingeniero De Servicio De Campo: Clasificación Avanzada

Tomra; Sevilla; Remote; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

The Principal Statistical Programmer at Cytel works across sponsor clinical trials, delivering SDTM/ADaM specifications and datasets with SAS and R. You will oversee CRO programmers to ensure high-quality outputs and timely delivery, while supporting regulatory submissions and study reports.

This fully remote role offers autonomy to drive programming activities across therapeutic areas, with collaboration to senior biostatistics leadership within Cytel.

Qualifikationen

• Extensive SAS and R programming experience in clinical trials.
• Experience delivering SDTM/ADaM datasets and define.xmls.
• Proven ability to oversee CRO programming deliverables and timelines.

Aufgaben

• Generate SDTM and ADaM specifications and datasets for multiple studies.
• Develop SAS programs to create tables, listings, and figures.
• Deliver high-quality SAS and R programs for regulatory submissions and publications.
• Oversee CRO programmers to ensure consistency and on-time delivery.
• Support preparation of clinical study reports and DSURs.

Kenntnisse

SAS programming

R programming

Statistical programming leadership

Clinical trial data analysis

Tools

SDTM

ADaM

Jobbeschreibung

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