Senior/Principal Programmer

PHASTAR; United Kingdom; On-site; GBP 40,000 - 60,000

Job description

Overview

THE COMPANY

Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the 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.

What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet!

THE ROLE

We are seeking a Senior/Principal Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. 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. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment.

This position is remote (although 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 independent technical expert
3. Program complex non-efficacy outputs/figures
4. Perform Senior Review and Deliver QC of non-statistical output
5. Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
6. Validate and perform User Acceptance Testing (UAT) on standard macros
7. Identify macros requirements, communicate and perform training
8. Create, QC and update complex dataset specifications (including efficacy) for single/multiple studies, ISS/ISEs, etc.
9. Implement and coordinate 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. Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
13. Implement and coordinate the development and maintenance of PHASTAR CRT tools
14. Become familiar with and follow study documentation
15. Initiating projects and ideas for furthering programming development
16. Ensure the principles in the PHASTAR checklist are followed rigorously
17. Develop archiving systems and processes
18. Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery
19. Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
20. Responsible for study level resources
21. Attend and input to company resourcing meeting
22. Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
23. Persuade stakeholders to follow best practice within a trial
24. Develop and deliver company-wide training as and when required
25. Identify areas where new processes are required
26. Create, review and update processes and SOPs
27. Take responsibility for study compliance with SOPs and processes

Qualifications

1. Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
2. SAS Programming Experience within the pharmaceutical industry
3. Good awareness of clinical trial issues, design, and implementation
4. Experience of regulatory submissions and associated industry guidance
5. Familiarity with GCP and regulatory requirements
6. Knowledge of SDTM and ADaM CDISC standards

APPLY NOW

With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is 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’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.

Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK, France, Spain or Germany as this role can be carried out remotely.

Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.