Senior Modern Workplace Architect

Minsait; Gijón; A distancia; EUR 70.000 - 120.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated team working with a global pharmaceutical client. You will lead programming activities, ensure data quality, and contribute to regulatory submissions.

Responsibilities include generating SDTM/ADaM specs, developing SAS and R programs, overseeing CRO deliverables, and aligning with FDA guidelines for submissions.

Formación

• Extensive experience in clinical trial programming and data handling.
• Strong knowledge of SDTM and ADaM data standards and datasets.
• Experience coordinating with CROs and external vendors.

Responsabilidades

• Generate SDTM and ADaM specifications and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs for regulatory submissions and publications.
• Oversee CRO programmers to ensure timely, compliant deliverables.
• Support clinical study reports, DSURs, and exploratory analyses.
• Adhere to FDA regulations and good clinical practice for submissions.

Conocimientos

SAS programming

R programming

SDTM/ADaM

Descripción del empleo

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 and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and