Fortrea

As a Principal Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex projects for renowned, innovative and global top pharmaceutical companies.

You will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety and Biometrics. This may be for either/or in-house programmed or out-sourced studies in either their Early or Late Phase team. It is a great opportunity to see more how this works from a Big Pharma perspective, whilst still being part of a global CRO with opportunity for future career growth.

This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas.

Summary of Responsibilities:

• Define and document detailed requirements and functional specifications for automation tools supporting statistical programming and regulatory submissions.
• Design and develop User Acceptance Testing (UAT) plans and scenarios.
• Prepare comprehensive validation documentation, including use cases and process flow diagrams.
• Develop and maintain utilities using Python, SAS, and R.
• Oversee and contribute to the development lifecycle, ensuring adherence to quality and compliance standards.
• Plan, coordinate, and support testing activities to validate tool functionality and performance.
• Lead the organization and execution of structured testing processes.
• Communicate directly with clients to plan project activities, provide updates, and report progress.
• Facilitate client meetings, including workshops, presentations, and status updates.
• Support project managers in project planning, task tracking, and resource coordination.

Qualifications (Minimum Required):

• Minimum of 4 years of experience in clinical trials, with a strong understanding of clinical research processes and CDISC standards.
• Proven experience leading statistical programming activities in clinical studies.
• Hands-on experience with regulatory submission processes and requirements.
• SAS (advanced level).
• Python (basic or intermediate level).
• Familiarity with R is a plus, but not mandatory.
• Excellent communication skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

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