Senior Clinical Data Coordinator I

Phastar; Vitoria; Remote; EUR 90,000 - 120,000; Full time

Job summary

Phastar is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a sponsor-dedicated role embedded with a global pharmaceutical client. You will independently manage programming activities, develop SDTM/ADaM deliverables, and oversee CRO programmers to ensure high-quality data analyses and reporting across studies.

You will work with minimal supervision, contributing expert technical support and delivering complex datasets, tables, listings, and figures for regulatory

Qualifications

• Experienced statistical programmer in clinical trials.
• Ability to develop SDTM/ADaM specifications and define.xml.
• Deliver high-quality programming outputs (tables, listings, graphs).

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 high-quality SAS and/or R programs tailored to clinical development needs.
• Oversee CRO programming activities to ensure consistency and quality.

Skills

SAS programming

R programming

Clinical statistics

CDISC SDTM/ADaM

Data analysis

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