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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 48000 - 72000 £ 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. Plus, it’s super easy!
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 highlight your experience in programming and statistical analysis, especially in oncology. We want to see how your skills match the job requirements, so don’t hold back on showcasing relevant projects!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention your experience with regulatory submissions and any specific projects that relate to the responsibilities listed in the job description.
Showcase Your Technical Skills: Since advanced SAS programming knowledge is key, make sure to highlight your technical skills prominently. We love seeing examples of how you've used these skills in past roles, especially in clinical drug development.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it makes the whole process smoother for everyone involved.
How to prepare for a job interview at ePharmIT
✨Know Your Stuff
Make sure you brush up on your SAS programming skills and be ready to discuss your experience with CDISC standards. Familiarise yourself with the specifics of oncology projects, as this is essential for the role.
✨Showcase Your Experience
Prepare examples from your past work that highlight your involvement in data submission strategies and regulatory responses. Be ready to explain how you've managed legacy data or contributed to TFLs in previous projects.
✨Understand the Company
Research the pharmaceutical brand you're interviewing with. Knowing their recent projects or any news related to their clinical trials can help you tailor your answers and show genuine interest in their work.
✨Ask Smart Questions
Prepare insightful questions about their programming processes or how they handle data transparency. This not only shows your enthusiasm but also helps you gauge if the company aligns with your career goals.