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- Tasks: Lead programming for clinical trials and manage global projects with a focus on compliance.
- Company: Dynamic pharmaceutical company dedicated to innovation in drug development.
- Benefits: Competitive salary, remote work options, and opportunities for professional growth.
- Other info: Join a collaborative team and enhance your skills in a fast-paced environment.
- Why this job: Make a real impact in healthcare by supporting groundbreaking clinical research.
- Qualifications: Bachelor’s or Master’s degree in relevant fields with significant experience in clinical research.
The predicted salary is between 56880 - 56880 ÂŁ per year.
Location: Harlow, Essex (England). Contract: 2 years. Salary: approximately ÂŁ56,880 per annum. 100% remote access via VDI.
Position Summary
Senior Manager / R&D Programmer providing comprehensive programming support for clinical trials. Manages timely and accurate execution of programming components, independently handles global and cross‑functional projects, and delivers analysis datasets, TLFs, and e‑submission packages in compliance with regulatory standards.
Responsibilities
- Develop, debug, and enhance SAS programs for safety and efficacy datasets and TLFs.
- Produce ADaM specifications and regulatory‑compliant analysis datasets.
- Support CDISC‑based e‑submissions and standardize GSD deliverables across study projects.
- Communicate program status, resource gaps, and issues to management, Stat and DM teams.
- Provide input on process improvement opportunities.
- Supply programming support for publications of marketed drugs.
Education and Experience
Bachelor’s or Master’s Degree in Science, Statistics, Information Technology, or equivalent. Relevant experience: BSc + 5 years or MSc + 4 years in a pharmaceutical or clinical research setting. Proficient knowledge of clinical trials, drug development process, CDISC SDTM and ADaM standards, and statistical concepts. Demonstrated SAS proficiency for analysis datasets, TLFs, eSUB components, and other software (e.g., Pinnacle 21, XML). Ability to work independently and in a team environment.
Functional Knowledge
- Expert-level SAS programming and problem resolution.
- In-depth knowledge of CDISC e‑submission (ADaM dataset creation, TLGs, BIMO inspections).
- Solid understanding of statistical models for efficacy data analysis.
- Advanced knowledge of government regulations (CDISC, ICH) across therapeutic areas.
Job‑Specific Competencies
- Exemplary problem‑solving, solution recommendation, and action management.
- Effective communication fostering common understanding and actionable outcomes.
- Strong oral and written communication skills.
R & D Programmer - Senior Manager employer: Kinetic plc
Contact Detail:
Kinetic plc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R & D Programmer - Senior Manager
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work in R&D 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 or a presentation that highlights your SAS programming projects and any successful e-submissions you've been part of. This will give you an edge during interviews.
✨Tip Number 3
Practice makes perfect! Get ready for technical interviews by brushing up on your SAS knowledge and problem-solving skills. Mock interviews with friends can help you feel more confident.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and take the initiative to connect directly with us.
We think you need these skills to ace R & D Programmer - Senior Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the R&D Programmer role. Highlight your experience with SAS programming and any relevant projects you've worked on. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background in clinical trials makes you a perfect fit. We love seeing enthusiasm and a personal touch!
Showcase Your Problem-Solving Skills: In your application, don’t forget to mention specific examples of how you've tackled challenges in previous roles. We value problem-solving abilities, especially in programming and data analysis, so let us know how you’ve made an impact!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at StudySmarter!
How to prepare for a job interview at Kinetic plc
✨Know Your SAS Inside Out
Make sure you brush up on your SAS programming skills before the interview. Be ready to discuss specific projects where you've developed, debugged, or enhanced SAS programs, especially for safety and efficacy datasets. Highlight your experience with ADaM specifications and how you've ensured compliance with regulatory standards.
✨Understand CDISC Standards
Familiarise yourself with CDISC SDTM and ADaM standards as they are crucial for this role. Be prepared to explain how you've applied these standards in past projects, particularly in relation to e-submissions and standardising deliverables. This shows that you not only know the theory but can also apply it practically.
✨Communicate Effectively
Since effective communication is key, practice articulating your thoughts clearly. Think of examples where you've communicated program status or resource gaps to management or cross-functional teams. This will demonstrate your ability to foster understanding and drive actionable outcomes.
✨Showcase Problem-Solving Skills
Prepare to discuss specific challenges you've faced in programming and how you resolved them. Highlight your exemplary problem-solving abilities and any process improvements you've implemented. This will show that you're not just a programmer but a proactive manager who can lead projects successfully.