Técnico/A Senior Automatización

Suitelec; Córdoba; A distancia; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer to be fully embedded with a pharmaceutical client. You will implement all reporting and analysis activities for sponsor trials, delivering SDTM/ADaM outputs via SAS and R.

As a senior programmer, you will oversee CRO deliverables, support regulatory submissions, and ensure high-quality data analysis in a remote capacity.

Formación

• Extensive experience as a statistical programmer in clinical trials.
• Proficiency in SAS and R for program development and data analysis.
• Strong knowledge of SDTM and ADaM standards.
• Experience supporting regulatory submissions and audits.
• Ability to work remotely with minimal supervision.

Responsabilidades

• Generate SDTM and ADaM specifications and define.xml for multiple studies.
• Develop SAS and R programs to create datasets, listings, tables and graphs.
• Deliver high-quality programming outputs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Contribute to trial reports, regulatory submissions, DSURs and exploratory analyses.
• Follow FDA regulations and GMP guidelines for electronic submissions.
• Develop and maintain programming standards, tools, and documentation.
• Assist in CRF development and data validation plans.

Conocimientos

Advanced SAS programming

R programming

SDTM/ADaM expertise

Regulatory submissions

CRO oversight

Herramientas

SAS

R

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/or author SOPs and/or Work Instructions related to statistical programming practices