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- Tasks: Lead statistical programming for clinical trials, ensuring quality and compliance with industry standards.
- Company: Tech Observer is a forward-thinking company focused on innovative solutions in clinical data management.
- Benefits: Enjoy flexible working options, competitive salary, and opportunities for professional growth.
- Why this job: Join a dynamic team that values innovation and collaboration while making a real impact in healthcare.
- Qualifications: Experience in statistical programming, proficiency in SAS, and knowledge of GCP and CDISC standards required.
- Other info: Opportunity to work across UK and Europe with a diverse team of professionals.
The predicted salary is between 48000 - 72000 £ per year.
Sr Manager HR & Operations with expertise in talent acquisition and development.
About the Role
Clinical Programmer (SCP) plays a pivotal role in supporting clinical research by developing, validating, and maintaining statistical programs and datasets. Collaborating with Biostatisticians, Clinical Data Managers, and cross-functional teams, the Senior Clinical Programmer ensures high-quality, timely deliverables that meet regulatory standards and study objectives. This role requires advanced SAS programming expertise, strong problem-solving skills, and the ability to mentor junior team members.
Responsibilities
- Program customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies.
- Analyze protocol, SAP, existing shells/templates as needed to understand structure and content of data.
- Prepare documentation for programs.
- Prepare documentation describing all datasets and variables within, including derived variables, and the project as a whole.
- Create SAS datasets of clinical data from clinical databases.
- Create status and efficacy datasets.
- Create project-specific macros and formats.
- Create study reports using SAS or Program R.
- Load client data from other platforms and other software packages.
- Prepare data to be sent to clients and as needed for other external transfers and data imports.
Thorough understanding of the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.
Required Skills
- Advanced SAS programming expertise, strong problem-solving skills, and the ability to mentor junior team members.
- Bachelor’s degree or equivalent combination of Education/Training/Experience is required. A degree in a scientific, medical, or technological discipline is preferred.
- A minimum of 3 years of clinical trial or clinical data management experience or similar industry experience/training is required.
- Prior trial responsibility for the entire data management life-cycle is desirable.
- Working knowledge of EDC studies is required and SAS is preferred.
Qualifications for Essential Functions
- Ability to communicate effectively in the English language in person, by phone and in writing.
- Ability to lead functional meetings.
- Strong attention to detail and accuracy is a must.
- Excellent organizational skills.
- Demonstrated ability to manage multiple projects.
- Ability to work collaboratively, effectively, and productively in diverse organization structures.
- Ability to work independently, take initiative and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication.
- Ability to work in a team-oriented, collaborative environment.
- Ability to work positively within a continually changing environment.
- Ability to effectively prioritize and execute tasks in a high-pressure environment.
- Advanced computer skills and practical knowledge of MS Office and potentially project management software.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Research
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Principal Statistical Programmer employer: Tech Observer
Contact Detail:
Tech Observer Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Statistical Programmer
✨Tip Number 1
Familiarise yourself with the latest CDISC and FDA guidelines, as well as GCP standards. This knowledge will not only help you in interviews but also demonstrate your commitment to maintaining high-quality programming practices.
✨Tip Number 2
Network with professionals in the statistical programming field, especially those who work at Tech Observer or similar companies. Attend industry conferences or webinars to make connections and learn about potential job openings.
✨Tip Number 3
Showcase your problem-solving skills by preparing examples of how you've tackled challenges in previous projects. Be ready to discuss these during interviews to highlight your proactive approach and decision-making abilities.
✨Tip Number 4
Stay updated on new programming techniques and IT developments relevant to clinical trial data management. Mention any recent tools or technologies you've learned about in your conversations with recruiters or during interviews to demonstrate your initiative.
We think you need these skills to ace Principal Statistical Programmer
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a Principal Statistical Programmer at Tech Observer. Familiarise yourself with the specific programming guidelines, CDISC standards, and GCP requirements mentioned in the job description.
Tailor Your CV: Customise your CV to highlight relevant experience in statistical programming, particularly with SAS and clinical trial data management. Emphasise any previous roles where you adhered to industry standards and guidelines, as this will resonate well with the hiring team.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your problem-solving skills and proactive approach. Mention specific examples from your past work that demonstrate your ability to lead projects and improve processes within a statistical programming context.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is clear, concise, and free of mistakes, as attention to detail is crucial in this role.
How to prepare for a job interview at Tech Observer
✨Know Your Programming Standards
Familiarise yourself with the latest versions of CDISC, FDA Guidelines, and GCP. Be prepared to discuss how you have implemented these standards in your previous work, as this will demonstrate your commitment to quality and compliance.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled complex programming challenges in the past. Highlight your proactive approach and decision-making abilities, as these are crucial for a Principal Statistical Programmer role.
✨Understand the Role of Team Dynamics
Be ready to discuss your experience in leading teams or projects. Emphasise your ability to collaborate effectively with other departments and how you can contribute to improving processes within the Statistical Programming group.
✨Prepare for Technical Questions
Expect technical questions related to SAS programming and data management. Brush up on your knowledge of developing and reviewing SAS programs, as well as your experience with data validation and electronic data transfer.
