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- Tasks: Lead statistical programming for clinical trials, ensuring high-quality data and compliance.
- Company: Join Cytel, a leader in pharmaceutical innovation, dedicated to improving patient treatments.
- Benefits: Enjoy autonomy, remote work options, and the chance to make a real impact in healthcare.
- Why this job: Be at the forefront of drug development, collaborating with top professionals in a dynamic environment.
- Qualifications: Bachelor's degree in relevant fields and 7+ years of statistical programming experience required.
- Other info: Ideal for those passionate about data science and making a difference in clinical research.
The predicted salary is between 48000 - 72000 £ per year.
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you\’ll be at the heart of our client\’s innovation. As a Principal Statistical Programmer, you will be dedicated to a global pharmaceutical company that is driving the next generation of patient treatment, empowering individuals to work with autonomy and ownership. This position reports to the Director, Biostatistics and Programming in the FSP Services business unit at Cytel.
The Principal Statistical Programmer works independently with minimal supervision, tracks progress, and provides expert technical support to team members. We seek a highly experienced senior statistical programmer to work across various therapeutic areas, oversee CRO programmers, and ensure high-quality, consistent data summaries for clinical development programs.
Your responsibilities will include:
- Generating SDTM, ADaM specifications, datasets, reviewer\’s guides, and define.xml files for multiple studies.
- Developing SAS programs to generate datasets, listings, tables, and complex graphs.
- Delivering high-quality statistical programming results, including developing, validating, and maintaining SAS and/or R programs tailored to project needs.
- Overseeing CRO\’s programming deliverables to ensure quality and timeliness.
- Supporting clinical study reports, regulatory submissions, publications, and exploratory analyses.
- Understanding and adhering to FDA regulations affecting clinical trial data reporting.
- Contributing to the creation, maintenance, and validation of programming standards and macros.
- Participating in the development of CRFs, edit check specifications, and data validation plans.
- Reviewing and authoring data transfer specifications for external data vendors.
- Collaborating with internal and external partners to meet project timelines and goals.
- Reviewing and authoring SOPs and Work Instructions related to statistical programming.
To succeed, you should have:
- A minimum of a bachelor\’s degree in computer science, data science, mathematics, or statistics.
- At least 7 years of experience as a Statistical Programmer supporting drug development or related fields.
- Exceptional SAS programming skills and experience with statistical procedures in a clinical environment.
- Extensive knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations.
- Experience supporting regulatory submissions and interacting with regulatory authorities.
- The ability to work independently.
- Outstanding communication and leadership skills.
Preferred qualifications include prior experience with pharmacokinetic data, neuroscience, and proficiency in additional languages or tools such as R, Python, Java, Shiny, Markdown, Unix/Linux, and git.
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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 with professionals in the pharmaceutical industry, especially those who work in statistical programming. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in the field.
✨Tip Number 2
Familiarise yourself with CDISC standards and FDA regulations, as these are crucial for the role. Consider taking online courses or certifications that focus on these areas to enhance your knowledge and demonstrate your commitment.
✨Tip Number 3
Showcase your SAS programming skills by working on personal projects or contributing to open-source projects. This will not only improve your skills but also provide tangible examples of your expertise to discuss during interviews.
✨Tip Number 4
Prepare for interviews by reviewing common questions related to statistical programming and clinical trials. Be ready to discuss your previous experiences, particularly how you've handled complex datasets and ensured quality in your programming deliverables.
We think you need these skills to ace Principal Statistical Programmer FSP
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in statistical programming, particularly with SAS and any other tools mentioned in the job description. Emphasise your years of experience and specific projects that align with the responsibilities outlined.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your understanding of clinical trial methodologies. Mention how your skills can contribute to the innovation at Cytel and provide examples of past successes in similar roles.
Highlight Technical Skills: In your application, clearly list your technical skills, especially those related to SAS programming, CDISC standards, and any additional languages or tools you are proficient in. This will demonstrate your capability to meet the job requirements.
Showcase Leadership Experience: If you have experience overseeing teams or mentoring junior programmers, make sure to include this in your application. Highlighting your leadership skills will show that you can work independently while also supporting others, which is crucial for this role.
How to prepare for a job interview at Cytel Inc
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with SAS programming and any other relevant tools like R or Python. Highlight specific projects where you developed datasets or statistical analyses, as this will demonstrate your technical proficiency and problem-solving skills.
✨Understand Regulatory Standards
Familiarise yourself with FDA regulations and CDISC standards, as these are crucial in the pharmaceutical industry. Be ready to explain how you've adhered to these standards in past roles, which will show your understanding of compliance in clinical trials.
✨Demonstrate Leadership and Collaboration
Since the role involves overseeing CRO programmers and collaborating with various stakeholders, share examples of how you've successfully led teams or worked with cross-functional groups. This will highlight your leadership skills and ability to work autonomously.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think of situations where you had to troubleshoot programming issues or ensure data quality under tight deadlines, and be ready to discuss your approach and outcomes.