Especialista De Crecimiento E-Commerce Y Cro

Porcelana De Sargadelos S.L; Marín; Remote; EUR 70,000 - 110,000; Full time

Job summary

Porcelana De Sargadelos S.L is seeking a Senior/Principal Statistical Programmer (Remote) to support a global pharmaceutical client. You will drive SAS and R programming, generate SDTM/ADaM datasets, listings, tables and figures, and ensure outputs meet regulatory standards.

Reporting to Biostatistics leadership, you will oversee CRO programmers, support clinical study reports and regulatory submissions, and contribute to standards and validation with a high degree of autonomy.

Qualifications

• Extensive experience in clinical development programming with SAS and R.
• Proven ability to deliver SDTM/ADaM specifications and define.xml.
• Experience overseeing CRO programmers and delivering high-quality outputs.
• Knowledge of FDA regulations, GCP, and regulatory submissions.
• Ability to work with minimal supervision and track progress.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs generating datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results and maintain SAS/R programs.
• Oversee CRO programmers' deliverables to meet timelines across studies.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses.
• Ensure compliance with FDA regulations and electronic submission guidelines.
• Contribute to standards development for tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide review and quality checks of programming outputs.

Skills

Statistical programming

CRO oversight

Regulatory compliance (FDA/GCP)

Tools

SAS

R

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