Senior Programmer - Oncology

Overview

THE COMPANY

Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology, and medical device organizations to provide expertise and processes to manage and deliver on-time, quality biostatistics, programming, data management, and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China, and Japan, Phastar is the second-largest specialized biometrics provider globally and the largest in the UK.

Our unique approach to data analysis, "The Phastar Discipline," has led us to build a reputation for outstanding quality.

With this as our core focus, we're looking for talented individuals who share our passion for quality and technical expertise to join our team.

Why Phastar

Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction, and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun, and friendly environment.

Additionally, when you join our team, Phastar will plant a tree in your honor as part of our Environmental, Social, and Governance (ESG) initiatives. So, not only will you get your dream job, but you'll also be helping to save the planet!

The Role

We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to high quality while adhering to deadlines. The role requires excellent knowledge of CDISC SDTM and ADaM implementation guidelines, with the ability to work independently in this area. Responsibilities include producing, reviewing, and updating complex dataset specifications (including efficacy), creating and debugging complex macros, reviewing Statistical Analysis Plans (SAPs), and output shells, providing a team-oriented approach, managing workload proactively, and learning new skills.

This position is remote (though it can be office-based or hybrid depending on your location) and may involve occasional travel to events throughout the year.

Responsibilities

• Program and validate datasets and SDTMs, including complex efficacy and labs.
• Become an independent technical expert.
• Program complex non-efficacy outputs/figures.
• Perform senior review and deliver QC of non-statistical output.
• Develop and implement standard macro libraries and study-specific macros.
• Validate and perform User Acceptance Testing (UAT) on macros.
• Identify macro requirements, communicate, and provide training.
• Create, QC, and update complex dataset specifications (including efficacy) for studies and reports.
• Implement and maintain Phastar standards specifications.
• Provide consultancy, advice, and training on SDTM, ADaM, and CRT standards.
• Stay informed about upcoming changes to CRT and define.xml standards and regulatory guidelines.
• Develop and maintain CRT tools.
• Follow study documentation and initiate programming projects for development.
• Ensure adherence to Phastar checklists and develop archival systems.
• Act as lead programmer on multiple studies, ensuring quality and timely delivery.
• Coordinate with statisticians and project managers regarding resourcing and deliverables.
• Manage study-level resources and participate in resourcing meetings.
• Serve as the programming point of contact for the team, ensuring cohesive functioning.
• Promote best practices within trials.
• Develop and deliver company-wide training as needed.
• Identify and implement new processes and update SOPs.

Qualifications

• BSc or higher in Computer Science, Mathematics, or related scientific discipline.
• SAS programming experience within the pharmaceutical industry.
• Good understanding of clinical trial issues, design, and implementation.
• Experience with regulatory submissions and industry guidance.
• Familiarity with GCP and regulatory requirements.
• Knowledge of SDTM and ADaM CDISC standards.

Apply Now

Join us at a pivotal time in clinical trial data management. We offer flexible working, structured training, competitive salary, and benefits. We are open to candidates across the UK, Germany, Spain, or France, as this role can be performed remotely.

Phastar is committed to equal opportunities and fostering a diverse workforce. We value your potential and suitability for the role above all else.