Perito De Riesgos Técnicos — Nivel Intermedio (Ingeniería)

Quironprevencion; Córdoba; Remote; EUR 65,000 - 90,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client, supported by Cytel. You will drive reporting and analysis activities for sponsor trials across therapeutic areas, implementing regulatory-ready outputs and collaborating with CROs.

The role requires extensive SAS/R expertise, experience with SDTM/ADaM, and the ability to work with autonomy within a global team. Regulatory knowledge and quality delivery are essential.

Qualifications

• Senior-level statistical programming experience in clinical trials.
• Experience delivering SDTM/ADaM specifications and datasets.
• Ability to oversee CRO programming deliverables and ensure timelines.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, and define.xml.
• Develop SAS programs for datasets, tables, listings, graphs.
• Deliver high-quality SAS/R outputs for regulatory submissions and reports.
• Review CRO deliverables and ensure compliance with timelines.
• Support preparation of clinical study reports and submissions.
• Adhere to FDA guidelines and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Collaborate with CROs and vendors to meet project goals.
• Develop CSFs, edit checks, and data validation plans.

Skills

SAS Programming

R Programming

SDTM

ADaM

Cros- Functional Oversight

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 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