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- Tasks: Lead programming efforts in clinical drug development and manage data submissions.
- Company: Global pharmaceutical brand expanding its programming and statistical teams.
- Benefits: Fully remote work, competitive contract rates, and opportunities for professional growth.
- Other info: Join a dynamic team with a focus on oncology and regulatory submissions.
- Why this job: Make a real impact in healthcare by working on innovative drug development projects.
- Qualifications: BSc in relevant field and advanced SAS programming skills required.
The predicted salary is between 36000 - 60000 £ per year.
Our client is a global pharmaceutical brand who are expanding their programming and statistical teams. They are currently looking for senior level programmers who will be engaged on initial 12 month contracts on a fully remote basis.
Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.
Key requirements include:- Collaborate with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project, including but not limited to the following:
- Data submission strategy (e.g., managing legacy data, pooling data)
- Oncology experience essential, preferably study lead experience
- Responses to regulatory agency queries
- Tables Figures and Listings (TFLs)
- Development Safety Update Reports (DSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Office of Scientific Investigations (OSI) data sets and listings
- Regulatory and/or Payer submission related analysis data sets and/or TFLs
- Associated quality and process documentation as per applicable business processes
- Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
- Pharmacokinetics/pharmacodynamics data preparation and analysis
- Manipulating and analyzing adjudicated data
- Data preparation and analysis for Global Medical Affairs work
- Clinical Trial Transparency deliverables (data de-identification, results posting files)
- Timely upload of documents to eTMF
- BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
- Advanced SAS programming knowledge and experience.
- Knowledge of database set-up and report publishing requirements.
- Advanced knowledge of technical and regulatory requirements related to the role.
- Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.
- Advanced knowledge and experience of clinical drug development or healthcare.
Senior Statistical Programmer (Contract) employer: ePharmIT
Contact Detail:
ePharmIT Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Statistical Programmer (Contract)
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in programming or clinical trials. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Show off your skills! Prepare a portfolio showcasing your previous projects, especially those related to oncology and regulatory submissions. This will give potential employers a clear picture of what you can bring to the table.
✨Tip Number 3
Ace the interview by doing your homework! Research the company’s recent projects and challenges in drug development. This will help you tailor your answers and show that you're genuinely interested in their work.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge over other candidates. Let’s get you that dream job!
We think you need these skills to ace Senior Statistical Programmer (Contract)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Statistical Programmer role. Highlight your oncology experience and any relevant programming projects you've worked on. We want to see how your skills match up with what we're looking for!
Showcase Your Skills: Don’t just list your qualifications; showcase them! Use specific examples of your advanced SAS programming knowledge and any experience with CDISC standards. This helps us see your expertise in action.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Explain why you're passionate about this role and how your background makes you a perfect fit. We love seeing enthusiasm and a personal touch in applications.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at ePharmIT
✨Know Your Stuff
Make sure you brush up on your SAS programming skills and understand the key concepts of clinical drug development. Familiarise yourself with CDISC standards and be ready to discuss how you've applied these in past projects.
✨Show Your Oncology Experience
Since oncology experience is essential, prepare specific examples from your previous roles where you led studies or contributed significantly. Highlight any challenges you faced and how you overcame them to demonstrate your expertise.
✨Prepare for Regulatory Questions
Expect questions about your experience with regulatory submissions and how you’ve handled queries from agencies. Be ready to discuss your approach to data preparation and analysis for submissions like DSURs and PBRERs.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company’s programming processes or their approach to clinical trial transparency. This shows your genuine interest in the role and helps you assess if it’s the right fit for you.