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- Tasks: Lead statistical programming for clinical trials and ensure data integrity.
- Company: Join a global leader in healthcare innovation, Johnson & Johnson.
- Benefits: Attractive salary, comprehensive health benefits, and opportunities for remote work.
- Why this job: Make a significant impact on patient outcomes through data analysis and programming.
- Qualifications: 8+ years of experience in statistical programming with SAS/R, leadership skills required.
- Other info: Collaborative environment with a focus on professional growth and development.
The predicted salary is between 43200 - 72000 £ per year.
Responsibilities include:
- Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Creation of ADaM datasets based on current ADaM standards.
- Creation of Tables, Listings and Figures following J&J specifications.
- Creation of Subject Narratives following J&J templates to support Narrative development.
- Creation of other ancillary data streams including clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).
- QC of all programmed output.
- Creation and/or maintenance of detailed specification documentation.
- Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
- Includes support for standalone studies as well as integration of data across studies.
- The service holder is responsible to design, develop and maintain SAS code that is generic and that covers many trial types, can run on many study designs and meet study specific situations based on high reliable study metadata specifying the design and study specific situations.
- The service holder defines and maintains standard clinical data analysis metadata for use in clinical trials, including the traceability from Analysis Datasets and Analysis Results (ADaM) to Study Data Tabulation Datasets (SDTM).
- The service holder pre-configures the standards in line with the data lifecycle plan while maintaining the traceability and lineage of the data.
- The service holder documents and correctly manages the lineage between master standards and the many pre-configured standards.
Minimum qualifications:
- 8+ years of experience, demonstrating increasing responsibilities.
- At least 2+ years of trial lead experience preferably as the lead for a team of programmers OR at least 2+ years of experience developing SAS/R solutions that are implemented broadly across clinical programs or a therapeutic area.
- Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
- Ability to communicate with cross-functional teams and gather feedback for study specifications and/or data issues.
- Experience reviewing and writing data specifications.
- High level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data.
Principal Statistical Programmer FSP employer: Cytel Inc
Contact Detail:
Cytel Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Statistical Programmer FSP
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Johnson & Johnson or similar companies. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your SAS and R skills. Be ready to discuss your experience with ADaM datasets and how you've tackled complex data issues in past projects. We want to see your problem-solving skills in action!
✨Tip Number 3
Showcase your leadership abilities! If you've led a team of programmers or managed multiple projects, make sure to highlight these experiences. We love candidates who can juggle priorities and keep everything on track.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining our team and ready to dive into the world of clinical data analysis.
We think you need these skills to ace Principal Statistical Programmer FSP
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principal Statistical Programmer role. Highlight your experience with ADaM datasets, SAS programming, and any leadership roles you've held. We want to see how your skills match what we're looking for!
Showcase Your Experience: In your cover letter, don’t just list your qualifications; tell us about specific projects where you’ve created Tables, Listings, and Figures. We love seeing real examples of your work that align with our needs at StudySmarter.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use bullet points for key achievements and avoid jargon unless it’s relevant. We appreciate straightforward communication that gets to the heart of your experience.
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 shows you’re keen on joining the StudySmarter team!
How to prepare for a job interview at Cytel Inc
✨Know Your ADaM Standards
Make sure you brush up on the latest ADaM standards before your interview. Be ready to discuss how you've created ADaM datasets in the past and how you ensure compliance with regulatory requirements. This shows that you’re not just familiar with the standards, but that you can apply them effectively.
✨Showcase Your SAS Skills
Since this role heavily involves SAS programming, be prepared to talk about your experience with SAS (Base and Macro). Bring examples of how you've developed solutions that were implemented across clinical programmes. If possible, share specific challenges you faced and how you overcame them using your coding skills.
✨Demonstrate Leadership Experience
If you've led a team of programmers or managed projects, highlight this experience. Discuss how you handled competing priorities and ensured project success. This will show that you have the organisational and leadership skills necessary for the role.
✨Prepare for Cross-Functional Communication
Communication is key in this role, so think about times when you’ve worked with cross-functional teams. Be ready to share how you gathered feedback for study specifications or resolved data issues. This will demonstrate your ability to collaborate effectively and contribute to a team environment.
