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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
Networking is key! Reach out to professionals in the pharmaceutical industry, especially those with experience in statistical programming. Join relevant online forums or LinkedIn groups where we can share insights and job leads.
✨Tip Number 2
Prepare for virtual interviews by brushing up on your technical skills and being ready to discuss your oncology experience. We recommend practising common interview questions and having examples ready that showcase your expertise in SAS programming and regulatory submissions.
✨Tip Number 3
Don’t underestimate the power of a strong online presence! Make sure your LinkedIn profile is up-to-date and highlights your relevant skills and experiences. We can help you optimise it to attract recruiters looking for senior statistical programmers.
✨Tip Number 4
Apply directly through our website for the best chance at landing the role. We streamline the application process, making it easier for you to showcase your qualifications and get noticed by hiring managers.
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 your advanced SAS programming knowledge and any experience with CDISC standards. Use specific examples to demonstrate how you've applied these skills in past roles. 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 clear understanding of the job requirements, so make it count!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
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. The interviewer will likely want to know how you've applied your technical knowledge in real-world scenarios, especially in oncology.
✨Showcase Your Collaboration Skills
Since the role involves working closely with the Programming Leader and other team members, be prepared to share examples of how you've successfully collaborated on projects. Highlight any leadership roles you've taken, especially in managing data submission strategies or responding to regulatory queries.
✨Prepare for Technical Questions
Expect some technical questions related to data preparation and analysis, particularly around TFLs and DSURs. Practise explaining complex concepts in a simple way, as this will demonstrate your understanding and ability to communicate effectively.
✨Understand the Bigger Picture
Familiarise yourself with the overall clinical drug development process and how your role fits into it. Being able to discuss how your work impacts patient outcomes or regulatory compliance can set you apart from other candidates.