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- Tasks: Transform real-world data into CDISC-compliant datasets using R for an exciting Atrial Fibrillation project.
- Company: Join a dynamic research team focused on innovative health solutions.
- Benefits: Gain valuable experience, work with experts, and enhance your programming skills.
- Other info: Collaborative environment with opportunities for professional growth and learning.
- Why this job: Make a real impact in healthcare while developing your statistical programming expertise.
- Qualifications: Experience in R programming and knowledge of CDISC standards required.
The predicted salary is between 40000 - 50000 £ per year.
Our client is seeking an experienced Statistical Programmer as a full time contractor for 6 months. The successful candidate will work closely with the Head of Statistics, an existing Statistical Programmer, and the wider research team to deliver on an exciting new project looking at the disease course of Atrial Fibrillation. The primary focus of the role is to support the creation of CDISC-compliant datasets, primarily SDTM and, where needed, ADaM, for an observational real-world study. The successful candidate will be expected to develop programming solutions and dataset specifications in R, based on the protocol, eCRF, and study requirements. Depending on sponsor requirements, the role may also include support for submission-readiness activities and preparation of associated documentation.
Key Responsibilities
- Lead the conversion of raw observational study data into CDISC SDTM datasets and drive the end-to-end development of ADaM datasets.
- Develop R code to transform source data into standardised structures.
- Review the study protocol, annotated CRF/eCRF, and related documentation to identify dataset and metadata requirements.
- Write trial design datasets/specifications, SDTM specifications, and ADaM specifications.
- Translate EDC/eCRF structures into detailed SDTM mapping specifications, including derivation and transformation logic.
- Prepare and maintain key submission-supporting documents, including: SDTM Review Guide, ADaM Review Guide, define.xml, controlled terminology / codelist documentation.
- Validate datasets and identify and resolve issues using Pinnacle 21 / OpenCDISC.
- Contribute to establishing a robust and reproducible programming workflow using GitHub and relevant R-based packages.
- Work collaboratively with statisticians, research strategists, and the existing statistical programmer to ensure datasets and documentation are accurate and fit for purpose.
- Support preparation of submission packages, if required.
- Perform independent double-programming and validation of datasets to ensure adherence to CDISC guidelines prior to sponsor delivery.
- Contribute to good programming practice, quality control, and documentation standards across the project.
Person Specification
Essential Experience and Skills
- Proven experience converting observational / real-world study data into CDISC SDTM and, coupled with deep, hands-on experience generating ADaM datasets and specifications from scratch.
- Strong hands-on programming experience in R, including building codebases and derivations.
- Strong experience with CDISC implementation and submission-supporting documentation.
- Experience using R-based CDISC/pharmaverse tools such as: sdtm.oak, admiral, other relevant pharmaverse packages.
- Experience writing SDTM and ADaM specifications directly from protocol and CRF/eCRF documentation.
- Experience converting annotated CRFs / EDC structures into detailed mapping specifications and transformation logic.
- Familiarity with preparing define.xml, review guides, and controlled terminology documentation.
- Experience validating datasets using Pinnacle 21 or equivalent CDISC validation tools.
- Experience using GitHub for version control, code management, and reusable workflows.
- Strong attention to detail and commitment to quality and reproducibility.
Desirable
- Previous experience supporting regulatory submission packages.
- Experience in cardiovascular, thrombosis, or other observational registry studies.
- Familiarity with biomarker, laboratory, and patient-reported outcome data.
- Working knowledge of SAS, although this is not essential for this role.
Statistical Programmer R employer: Pop Science
Contact Detail:
Pop Science Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Statistical Programmer R
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant meetups, and engage with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Show off your skills! Create a portfolio showcasing your R programming projects, especially those related to CDISC datasets. This will give potential employers a taste of what you can do and set you apart from the crowd.
✨Tip Number 3
Prepare for interviews by brushing up on common questions related to statistical programming and CDISC standards. Practice explaining your past projects and how you've tackled challenges in dataset creation and validation.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got some fantastic opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to keep track of your applications!
We think you need these skills to ace Statistical Programmer R
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience with CDISC SDTM and ADaM datasets. We want to see how your skills in R programming and dataset specifications align with the role, 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 excited about this project on Atrial Fibrillation and how your background makes you the perfect fit. We love seeing genuine enthusiasm and a clear connection to the role.
Showcase Your Technical Skills: Don’t forget to mention your hands-on experience with R and any relevant CDISC tools like Pinnacle 21 or OpenCDISC. We’re looking for someone who can hit the ground running, so highlight those technical skills that make you stand out!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to keep track of your application and ensure it gets the attention it deserves. Plus, it shows you’re keen to join our team!
How to prepare for a job interview at Pop Science
✨Know Your CDISC Inside Out
Make sure you brush up on your knowledge of CDISC standards, especially SDTM and ADaM. Be ready to discuss how you've previously converted observational study data into these formats, as this will show your practical experience and understanding of the requirements.
✨Show Off Your R Skills
Prepare to demonstrate your programming prowess in R. Bring examples of code you've written for transforming datasets and be ready to explain your thought process behind the derivations and transformations. This will highlight your hands-on experience and problem-solving abilities.
✨Familiarise Yourself with Submission Documentation
Get comfortable with the types of submission-supporting documents you'll need to prepare, like define.xml and review guides. Being able to discuss your experience with these documents will show that you're not just a programmer but also understand the bigger picture of regulatory submissions.
✨Collaboration is Key
Since you'll be working closely with statisticians and other team members, think of examples where you've successfully collaborated on projects. Highlight your communication skills and how you ensure accuracy and quality in your work, as teamwork is crucial in this role.