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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 programming and clinical trials. Join relevant online forums or LinkedIn groups to connect with others and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your technical skills and understanding the latest trends in oncology programming. We recommend practising common interview questions related to SAS programming and regulatory submissions to showcase your expertise.
✨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 experience in statistical programming. This can help recruiters find you more easily.
✨Tip Number 4
Apply directly through our website for the best chance at landing that contract! We often have exclusive listings and can keep you updated on new opportunities tailored to your skills in programming and clinical development.
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 align with the key requirements mentioned in the job description.
Showcase Relevant Experience: When writing your cover letter, focus on your past projects that relate to clinical drug development and regulatory submissions. We love seeing specific examples of your work that demonstrate your expertise in SAS programming and CDISC standards.
Be Clear and Concise: Keep your application clear and to the point. Use bullet points for your achievements and responsibilities to make it easy for us to read. We appreciate a well-structured application that gets straight to the good stuff!
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. 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 a Programming Leader, be prepared to share examples of how you've successfully collaborated on projects. Highlight any leadership roles you've taken on, especially in managing data submission strategies or responding to regulatory queries.
✨Prepare for Technical Questions
Expect some in-depth technical questions related to data preparation and analysis. Brush up on your knowledge of TFLs, DSURs, and PBRERs, and be ready to explain how you've handled these in past projects.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their current projects in clinical drug development or how they handle regulatory submissions. This shows you're engaged and serious about the position.