Principal/Senior Clinical Data Scientist

Precision Medicine Group; Murcia; Remote; EUR 65,000 - 90,000; Full time

Job summary

Precision Medicine Group, a sponsor-focused organization, seeks a Senior/Principal Statistical Programmer (SAS + R) to be fully embedded with one pharmaceutical client. This remote role involves leading programming tasks, overseeing CROs, and supporting regulatory submissions with autonomy.

The ideal candidate will generate SDTM/ADaM artifacts, develop complex analyses, and ensure high-quality, compliant deliverables across studies.

Qualifications

• Experience leading statistical programming for clinical development.
• Proficient in SAS and R programming for trials.
• Experience with SDTM/ADaM datasets and tables.
• Experience with regulatory submissions and publications.

Responsibilities

• Generate SDTM/ADaM specs, datasets, reviewer’s guides, and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver quality SAS/R programs; validate and maintain code across programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions, DSURs, and exploratory analyses.
• Adhere to FDA guidelines and regulatory requirements.

Skills

Statistical programming

Clinical development

CRO oversight

Tools

SAS

R

SDTM

ADaM

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.

• 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