Principal/Senior Programmer

PHASTAR; United Kingdom; Remote; GBP 40,000 - 80,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Senior Programmer zur Unterstützung in mehreren klinischen und nicht-klinischen Studien. Diese Schlüsselrolle erfordert Fachkenntnisse in SAS-Programmierung und CDISC-Standards, um qualitativ hochwertige Datensätze zu erstellen und zu validieren. Sie werden Teil eines preisgekrönten Teams, das sich für höchste Standards in der Datenanalyse einsetzt. Das Unternehmen bietet flexible Arbeitszeiten und ein unterstützendes Umfeld, in dem Sie Ihre Fähigkeiten weiterentwickeln können. Wenn Sie leidenschaftlich an der Verbesserung der klinischen Forschung interessiert sind, ist dies die perfekte Gelegenheit für Sie.

Benefits

Flexible Arbeitszeiten

Strukturierte Schulungs- und Entwicklungspläne

Unterstützendes Arbeitsumfeld

Teilzeitmöglichkeiten

Umweltinitiativen

Qualifications

• Erfahrung in SAS-Programmierung innerhalb der pharmazeutischen Industrie.
• Kenntnisse in SDTM und ADaM CDISC-Standards.

Responsibilities

• Programmieren und Validieren von Datensätzen und SDTMs.
• Entwicklung und Implementierung von Standardmakros für Studien.
• Führen von Schulungen und Beratung zu SDTM und ADaM.

Skills

SAS Programmierung

CDISC SDTM

CDISC ADaM

Datenmanagement

Regulatorische Einreichungen

Education

BSc in Informatik

BSc in Mathematik

BSc in verwandten Wissenschaften

Tools

Statistische Analyse-Software

Makros

Job description

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 supportive, fun, and friendly environment.

Additionally, as part of our Environmental, Social, and Governance (ESG) initiatives, we will plant a tree in your honor when you join our team. 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 excellent quality while adhering to deliverable timelines. The ideal candidate will have excellent knowledge of CDISC SDTM and ADaM implementation guidelines, working independently in this area; producing, reviewing, and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study-specific ISS/ISE and DSMB SAPs and output shells, with a view to commenting from a programming perspective. The candidate should have an excellent team work ethos, be proactive in managing workload, willing to help others, and eager to learn new skills in a team environment.

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

Responsibilities

1. Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
2. Become an independent technical expert.
3. Program complex non-efficacy outputs/figures.
4. Perform senior review and deliver QC of non-statistical output.
5. Develop the standard macro library and take responsibility for implementing standard macros within a study.
6. Validate and perform User Acceptance Testing (UAT) on standard macros.
7. Identify macro requirements, communicate, and perform training.
8. Create, QC, and update complex dataset specifications (including efficacy) for single/multiple studies, ISS/ISEs.
9. Implement and coordinate the development and maintenance of Phastar standard specifications.
10. Be an SDTM and ADaM expert, providing consultancy, advice, and training.
11. Be an CRT expert, providing consultancy, advice, and training.
12. Stay informed of upcoming changes to CRT and define.xml standards and regulatory guidelines.
13. Implement and coordinate the development and maintenance of Phastar CRT tools.
14. Familiarize with and follow study documentation.
15. Initiate projects and ideas for further programming development.
16. Ensure principles in the Phastar checklist are followed rigorously.
17. Develop archiving systems and processes.
18. Act as a lead programmer on multiple studies and projects, ensuring quality and timely delivery.
19. Liaise with Study Statisticians and Project Managers regarding resourcing and deliverables.
20. Be responsible for study-level resources.
21. Attend and contribute to company resourcing meetings.
22. Serve as the point of contact for programming issues within the team, proactively ensuring cohesive workflow.
23. Persuade stakeholders to follow best practices within a trial.
24. Develop and deliver company-wide training as needed.
25. Identify areas where new processes are required.
26. Create, review, and update processes and SOPs.

Qualifications

• Educated to BSc or above in Computer Science, Mathematics, or a related science discipline.
• SAS programming experience within the pharmaceutical industry.
• Good awareness of clinical trial issues, design, and implementation.
• Experience with regulatory submissions and associated industry guidance.
• Familiarity with GCP and regulatory requirements.
• Knowledge of SDTM and ADaM CDISC standards.

Apply Now

With the world's focus on clinical trial data, this is a fantastic time to join an award-winning, specialized biometric CRO renowned for its technical expertise, outstanding quality, and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We are committed to ensuring our employees achieve a healthy work-life balance within a supportive, fun, and friendly environment.

If you believe you have the right skills and motivation for this position, please apply! We are considering candidates located anywhere in the UK, Germany, Spain, or France, as this role can be performed remotely.

Phastar is committed to equal opportunity principles and practices, encouraging a diverse workforce. We employ individuals based on their suitability and potential for development, regardless of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief.