At a Glance
- Tasks: Lead projects, write SAS/R programs, and ensure quality in clinical data processing.
- Company: Global Clinical Research Organisation with a focus on innovation and quality.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Other info: Join a dynamic team with global reach and excellent career advancement opportunities.
- Why this job: Make a real impact in the life sciences industry while developing your programming skills.
- Qualifications: Experience in statistical programming and a strong understanding of clinical research.
The predicted salary is between 60000 - 80000 £ per year.
Tech Observer, a Global Clinical Research Organization (CRO) & FSP provider that has been supporting the Pharmaceuticals & Life Sciences Industry since 2005. We have offices in New Jersey, US (Headquarters), India, Denmark, UK & Singapore. Through our local partners, we extend our coverage to Australia, China, Malaysia, South Korea, Taiwan, Thailand, Vietnam, and other countries.
Job Responsibilities:
- Carry out all activities according to Tech Observer/Client SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).
- Ensure adherence to programming guidelines.
- Understanding of Protocol and SAP requirements.
- Lead the assigned project or task.
- Write SAS/R programs for development and QC of SDTM datasets, ADaM datasets and reports (i.e. Tables, Listings and Figures).
- Write SAS programs for development and QC of Randomization Schedule.
- Development and QC of SDTM and ADaM specifications.
- Development and QC of e-submission package for SDTM and ADaM.
- Review of study documents such as CRF, Metadata, Protocol, SAP and Mockshells.
- Demonstrate excellent problem-solving skills, a proactive approach and a willingness to take decisions on a regular basis.
- Perform function/project specific responsibilities as assigned.
- Demonstrate quick learning capabilities to improve programming and domain knowledge.
- Provide support in the driving system and process improvements, and to develop and implement solutions to improve efficiency and quality of clinical study data processing and reporting.
- Demonstrate 100% compliance and adherence to all SOPs.
- Prepare and implement standard operating procedures (SOP).
- Write complex SAS macros.
- Mentor junior statistical programmers and conduct knowledge sharing sessions.
Principal Statistical Programmer-FSP in Northampton employer: Tech Observer
Tech Observer is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for Principal Statistical Programmers to thrive. With a commitment to employee growth through mentorship and knowledge sharing, along with the opportunity to work on impactful projects in the Pharmaceuticals and Life Sciences sector, our team enjoys a supportive environment that values quality and efficiency. Located in New Jersey, our headquarters offers a dynamic setting with access to global resources and partnerships, enhancing both professional development and work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Statistical Programmer-FSP in Northampton
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We think you need these skills to ace Principal Statistical Programmer-FSP in Northampton
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Tech Observer!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Tech Observer that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Tech Observer!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Tech Observer, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Tech Observer
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Tech Observer that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Tech Observer’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.