Staff Product Designer

Moniepoint Inc.; Santa Cruz de Tenerife; À distance; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Moniepoint Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a pharmaceutical client framework. The role emphasizes autonomous programming and cross-functional collaboration to deliver compliant data packages for clinical trials.

The successful candidate will manage SDTM/ADaM deliverables, develop complex SAS/R code, and coordinate with CROs and internal teams to ensure timely regulatory submissions and high-quality analyses.

Qualifications

• Extensive experience in clinical development programming.
• Proficient in SDTM/ADaM specifications and define.xml artifacts.
• Strong knowledge of FDA regulations and GxP in clinical trials.
• Experience supervising CRO programming deliverables.

Responsabilités

• Develop SAS programs to produce datasets, listings, tables and graphs for multiple studies.
• Deliver high-quality statistical programming outputs and validation of codes.
• Oversee CRO programmers to ensure timely, accurate results.
• Support clinical study reports, regulatory submissions and DSURs.
• Comply with FDA guidelines and maintain programming standards.

Connaissances

SAS Programming

R Programming

Clinical Data Standards

ADaM

Regulatory Compliance

Data Analysis

Formation

Master's degree in Biostatistics or related field

Outils

SAS

R

Description du poste

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