Senior Clinical Data Coordinator I

Phastar; Oña; Remote; EUR 72,000 - 100,000; Full time

Job summary

Phastar is seeking a Senior/Principal Statistical Programmer (Remote) to work within sponsor-dedicated clinical projects. The role involves independent work with minimal supervision and oversight of CRO programmers to ensure high-quality data summaries and reporting for multiple studies.

The candidate will generate SDTM/ADaM specifications, develop SAS programs for datasets, listings, and tables, and deliver robust analytics and graphics for clinical development programs.

Qualifications

• Extensive experience in clinical trial programming.
• Strong understanding of SDTM and ADaM specifications.
• Experience leading or supervising CRO programming efforts.
• Ability to deliver high-quality statistical programming outputs for regulatory submissions.

Responsibilities

• Generate SDTM and ADaM specs, datasets, and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver validated SAS and/or R programs tailored to clinical development needs.
• Oversee CRO programmers to ensure consistency and quality across studies.

Skills

Statistical programming

CRO oversight

SDTM/ADaM knowledge

Clinical trial programming

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