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For Companies At a Glance
- Tasks: Lead programming activities for complex clinical trials and mentor junior team members.
- Company: Join a global CRO working with a top pharmaceutical company.
- Benefits: 100% remote work, competitive salary, and opportunities for career growth.
- Why this job: Make a real impact on innovative drug development while working from anywhere in EMEA.
- Qualifications: Degree in relevant field or equivalent experience in statistical programming.
- Other info: Collaborative environment with a focus on quality and innovation.
The predicted salary is between 36000 - 60000 £ per year.
Overview
As a Principal Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex projects for a renowned, innovative and global top pharmaceutical company. You will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety and Biometrics. It is a great opportunity to see more how this works from a Big Pharma perspective, whilst still being part of a global CRO with opportunity for future career growth. This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas. You can be 100% home-based in EMEA or you can work from our local office in your home country.
Responsibilities
- Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.
- Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs.
- Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses.
- Support/oversee submission activities (especially in late phase team).
- Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times.
- Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes.
Qualifications
- Ideally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
- In lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO or pharmaceutical company.
- Solid experience with complex clinical trials (minimum 5 years) and the corresponding data sets content (safety and efficacy) and endpoints.
- Ideally you will have knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.
- Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs.
- Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer\\\’s Guides and submission standards.
- An autonomous, collaborative work style, a curious mind and a keen attention to detail.
- Fluency in English – both verbal and written – is a must.
Learn more about our EEO & Accommodations request here.
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Principal Statistical Programmer - Sponsor Dedicated, EMEA employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Statistical Programmer - Sponsor Dedicated, EMEA
✨Tip Number 1
Network like a pro! Reach out to professionals in the industry on LinkedIn or at events. We can’t stress enough how important it is to make connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to statistical programming. We recommend doing mock interviews with friends or mentors to boost your confidence.
✨Tip Number 3
Showcase your skills! Create a portfolio of your work, especially any projects involving SDTM, ADaM, or TLF development. This will give you an edge and demonstrate your expertise to potential employers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Principal Statistical Programmer - Sponsor Dedicated, EMEA
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight your expertise in statistical programming, especially with SDTM and ADaM, to show us you’re the right fit for this role.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your background aligns with our needs. Don’t forget to mention your experience with complex clinical trials!
Showcase Your Technical Skills: We want to see your technical prowess! Be sure to include specific examples of your work with SAS, macros, and debugging. This will help us understand your capabilities and how you can contribute to our team.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates during the process!
How to prepare for a job interview at Fortrea
✨Know Your Stuff
Make sure you brush up on your knowledge of SDTM, ADaM, and TLF development. Be ready to discuss your experience with complex clinical trials and how you've managed programming activities in the past. This will show that you’re not just familiar with the terms but can apply them effectively.
✨Showcase Your Collaboration Skills
Since this role involves liaising with various departments, be prepared to share examples of how you've successfully collaborated with teams like Clinical, Medical Writing, and Safety. Highlight any specific projects where teamwork was key to success.
✨Demonstrate Your Problem-Solving Abilities
Think of instances where you had to debug SAS programs or tackle unexpected challenges in a project. Discuss your approach to problem-solving and how you ensure quality while meeting deadlines. This will illustrate your analytical skills and attention to detail.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to innovative drug development and how they support their employees' growth. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
