Senior Clinical Data Coordinator I

Phastar; Ibiza; Remote; EUR 68,000 - 90,000; Full time

Job summary

Phastar seeks a Senior/Principal Statistical Programmer (Remote) to work on sponsor-dedicated projects in the pharmaceutical sector. You will deliver SDTM/ADaM specifications and manage programming for multiple studies, with Cytel providing backing support and oversight for data delivery quality.

You will independently lead programming efforts, collaborate with statisticians, and oversee CRO programmers to ensure consistency and high-quality outputs across clinical trials.

Qualifications

• Requires extensive SAS programming experience and proficiency in R.
• Experience delivering SDTM/ADaM datasets and defining.xml.
• Strong knowledge of CDISC standards and GxP.
• Experience supervising CRO programmers is a plus.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer''s guides, and define.xml for studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming outputs and maintain SAS/R programs.
• Oversee CROs to ensure consistent, high-quality work.

Skills

SAS

R

SDTM

ADaM

GxP

Education

Bachelor's degree in Biostatistics or related field

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