Planificación Global Y Gestión De Materiales Senior – Flexible

Ingeteam; Badajoz; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven pharmacovigilance projects with a global pharmaceutical client. You will lead programming activities, develop SDTM/ADaM datasets, and deliver complex listings, tables and graphs using SAS and R, with high autonomy and collaboration with CROs.

The role emphasizes independence, regulatory compliance (GCP/FDA guidelines), and contribution to standards while supporting regulatory submissions and study

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 and graphs
• Deliver high-quality statistical programming results including SAS and/or R programs
• Oversee CRO's statistical programming deliverables to ensure high quality and timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs and exploratory analyses
• Understand and follow FDA regulations affecting reporting of clinical trial data
• Contribute to creation, maintenance, documentation, and validation of standards for programming tools and macros
• Develop CRFs, edit check specifications, and data validation plans
• Provide review

Job description

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