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- Tasks: Lead complex clinical trials and develop SAS programs for data analysis.
- Company: Join a top-tier pharmaceutical company dedicated to innovative drug development.
- Benefits: Enjoy remote work flexibility and a collaborative global team environment.
- Why this job: Make a real impact on global health while working with industry leaders.
- Qualifications: Degree in relevant field or equivalent experience in statistical programming required.
- Other info: Opportunity to work from home or local office; strong focus on innovation.
The predicted salary is between 36000 - 60000 £ per year.
As a Senior Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative and global top pharmaceutical companies. Oftentimes you will have the opportunity to lead studies through various phases of the clinical development plan and support submissions, regulatory questions, publications as well as ad hoc and post hoc requests.
In this role, you will develop and validate SAS programs for data presentations and analyses and provide programming support to your multidisciplinary global project team. This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas. Your expertise and your work as a statistical programmer have a direct impact on improving the health and lives of thousands of patients around the globe every day.
Your Responsibilities:
- Review SAPs and TFL shells from a programming perspective.
- Advise on the development of complex TFL shells from a programming perspective.
- Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets.
- Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs.
- Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs.
- Respond to QA and client audits and support qualification audits.
- Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming business.
- Maintain awareness of industry standards, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs).
Your Profile:
- Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
- In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in statistical programming for clinical trials.
- Solid professional experience as a statistical programmer within a biotech, CRO or pharmaceutical company.
- Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs.
- Proven professional experience with SDTMs, ADaM datasets (safety and efficacy) and TFLs.
- Solid knowledge of CDISC standards.
- Submission experience is ideal.
- Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail.
- Business fluency in English - both spoken and written - is a must.
Senior Statistical Programmer - Sponsor Dedicated employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Statistical Programmer - Sponsor Dedicated
✨Tip Number 1
Familiarise yourself with the latest CDISC standards and guidelines, as this knowledge is crucial for the role. Being able to discuss how you have applied these standards in previous projects can set you apart during interviews.
✨Tip Number 2
Network with professionals in the clinical programming field, especially those who work with top pharmaceutical companies. Attend industry conferences or webinars to make connections and learn about potential job openings.
✨Tip Number 3
Prepare to discuss specific examples of your experience with SAS programming, particularly in developing SDTM and ADaM datasets. Highlight any innovative solutions you've implemented to improve efficiency in your past roles.
✨Tip Number 4
Stay updated on current trends and challenges in the pharmaceutical industry, especially regarding clinical trials. This knowledge will help you engage in meaningful conversations during interviews and demonstrate your commitment to the field.
We think you need these skills to ace Senior Statistical Programmer - Sponsor Dedicated
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in statistical programming, particularly with SAS and clinical trials. Emphasise your familiarity with SDTMs, ADaM datasets, and any submission experience you have.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the impact of your work on patient health. Mention specific projects or experiences that demonstrate your skills and how they align with the company's goals.
Highlight Relevant Skills: In your application, clearly outline your technical skills, such as proficiency in SAS, debugging capabilities, and knowledge of CDISC standards. Use examples to illustrate how you've applied these skills in previous roles.
Proofread Your Application: Before submitting, thoroughly proofread your application materials for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a statistical programmer.
How to prepare for a job interview at Fortrea
✨Showcase Your Technical Skills
Be prepared to discuss your experience with SAS programming in detail. Highlight specific projects where you developed and validated SAS programs, and be ready to explain your approach to debugging and quality control.
✨Understand Clinical Trial Phases
Familiarise yourself with the different phases of clinical trials (I-III) and how statistical programming fits into each phase. This knowledge will demonstrate your understanding of the role's impact on drug development.
✨Discuss Regulatory Knowledge
Since the role involves responding to QA and client audits, be prepared to talk about your understanding of global regulatory requirements and industry standards, particularly CDISC standards. This shows you are well-versed in compliance.
✨Emphasise Collaboration and Communication
As a Senior Statistical Programmer, you'll work with multidisciplinary teams. Share examples of how you've successfully collaborated with others and communicated complex statistical concepts to non-technical stakeholders.
