At a Glance
- Tasks: Lead programming for clinical studies, ensuring quality and timely delivery of datasets.
- Company: Join Phastar, a top-rated global CRO known for its commitment to quality and employee satisfaction.
- Benefits: Enjoy flexible working hours, structured training, and a supportive, fun environment.
- Why this job: Make an impact in the healthcare sector while developing your skills in a collaborative team.
- Qualifications: BSc in Computer Science or related field; SAS programming experience preferred.
- Other info: Remote work available; tree planted in your honour as part of our ESG initiatives.
The predicted salary is between 43200 - 72000 £ per year.
Overview
Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that partners with pharmaceutical, biotechnology and medical device organizations to provide expertise in 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.
Why Phastar
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.
The Role
We are seeking a Principal Programmer to work across multiple clinical and non-clinical studies. Line management skills are essential, 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 is required, along with the ability to work independently in this area.
- Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
- Become an independent technical expert.
- Program complex non-efficacy outputs/figures.
- Perform Senior Review and Deliver QC of non-statistical output.
- Develop the standard macro library and implement standard macros within a study.
- Validate and perform User Acceptance Testing (UAT) on standard macros.
- Create, QC and update complex dataset specifications for single/multiple studies, ISS/ISEs.
- Implement and coordinate development and maintenance of PHASTAR standard specifications.
- Provide consultancy, advice and training as an SDTM and ADaM expert.
- Be aware of changes to CRT and define.xml standards and regulatory guidelines.
- Initiate projects and ideas for furthering programming development.
- Ensure the principles in the PHASTAR checklist are followed rigorously.
- Act as a Lead programmer on multiple studies and projects, ensuring quality and timely delivery.
- Liaise with Study Statistician and Project Manager regarding resourcing and deliverables.
- Attend and input to company resourcing meetings.
- Point of contact for programming issues for the team.
- Persuade stakeholders to follow best practice within a trial.
- Develop and deliver company-wide training as required.
- Create, review and update processes and SOPs.
Qualifications
- Educated to BSc or above within Computer Science, Mathematics or a Science related discipline.
- SAS Programming Experience within the pharmaceutical industry.
- Good awareness of clinical trial issues, design, and implementation.
- Experience of regulatory submissions and associated industry guidance.
- Familiarity with GCP and regulatory requirements.
- Knowledge of SDTM and ADaM CDISC standards.
Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce.
Senior/Principal Programmer employer: PHASTAR
Contact Detail:
PHASTAR Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior/Principal Programmer
✨Tip Number 1
Familiarise yourself with Phastar's unique approach, 'The Phastar Discipline'. Understanding their commitment to quality and how they manage data can give you an edge in interviews, showing that you're aligned with their values.
✨Tip Number 2
Brush up on your knowledge of CDISC SDTM and ADaM guidelines. Being able to discuss these standards confidently during your conversations will demonstrate your technical expertise and readiness for the role.
✨Tip Number 3
Network with current or former employees of Phastar on platforms like LinkedIn. They can provide insights into the company culture and expectations, which can help you tailor your approach when applying.
✨Tip Number 4
Prepare to discuss your experience with regulatory submissions and clinical trial issues. Highlighting specific examples from your past work can illustrate your capability and fit for the role.
We think you need these skills to ace Senior/Principal Programmer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in programming, particularly within the pharmaceutical industry. Emphasise your knowledge of CDISC SDTM and ADaM standards, as well as any line management skills you possess.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality and technical expertise. Mention specific projects or experiences that demonstrate your ability to manage datasets and outputs effectively, and how you align with Phastar's values.
Showcase Your Technical Skills: Detail your SAS programming experience and familiarity with regulatory submissions. Include examples of how you've implemented standard macros or contributed to developing macro libraries in previous roles.
Highlight Teamwork and Leadership: Since the role requires excellent teamwork and line management skills, provide examples of how you've successfully collaborated with others and led projects. This will show your ability to work cohesively within a team environment.
How to prepare for a job interview at PHASTAR
✨Showcase Your Technical Expertise
As a Senior/Principal Programmer, it's crucial to demonstrate your deep understanding of CDISC SDTM and ADaM guidelines. Be prepared to discuss specific projects where you've implemented these standards and how you ensured quality in your datasets.
✨Highlight Leadership Skills
Since the role involves line management, share examples of how you've successfully led teams or projects in the past. Discuss your approach to mentoring others and how you foster a collaborative team environment.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in programming or data management and how you overcame them, particularly in relation to regulatory submissions.
✨Emphasise Your Commitment to Quality
Phastar values outstanding quality, so be ready to talk about your personal standards for quality assurance. Discuss any processes you've developed or followed to ensure high-quality outputs and how you handle feedback and revisions.