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- Tasks: Lead statistical programming for clinical trials, ensuring high-quality data and compliance.
- Company: Cytel partners with top pharmaceutical companies to innovate patient treatments.
- Benefits: Enjoy autonomy, remote work options, and a supportive team environment.
- Why this job: Join a mission-driven company impacting global health while developing your skills in a dynamic setting.
- Qualifications: Bachelor's degree in relevant fields and 7+ years of statistical programming experience required.
- Other info: Ideal for those passionate about drug development and eager to make a difference.
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
Familiarise yourself with CDISC standards and FDA regulations, as these are crucial for the role. Being able to demonstrate your understanding of these guidelines during interviews will show that you are well-prepared and knowledgeable.
✨Tip Number 2
Highlight your experience with SAS programming and any additional tools like R or Python. Be ready to discuss specific projects where you've used these skills, as practical examples can set you apart from other candidates.
✨Tip Number 3
Network with professionals in the pharmaceutical industry, especially those who work in statistical programming. Engaging with them on platforms like LinkedIn can provide insights into the company culture and potentially lead to referrals.
✨Tip Number 4
Prepare to discuss your leadership and communication skills, as these are essential for overseeing CRO programmers. Think of examples where you've successfully led a team or communicated complex information clearly.
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 experience in drug development and familiarity with CDISC standards.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your ability to work independently. Mention specific projects or experiences that demonstrate your expertise in statistical programming and your understanding of FDA regulations.
Highlight Leadership Experience: Since the role involves overseeing CRO programmers, be sure to include any leadership or mentoring experience you have. Discuss how you've successfully led teams or projects in the past, focusing on outcomes and quality.
Showcase Communication Skills: Given the collaborative nature of the role, highlight your communication skills in both your CV and cover letter. Provide examples of how you've effectively communicated complex statistical concepts to non-technical stakeholders or collaborated with cross-functional teams.
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 generated SDTM or ADaM datasets, as well as your understanding of CDISC standards.
✨Demonstrate Leadership Skills
Since the role involves overseeing CRO programmers, share examples of how you've led teams or projects in the past. Discuss your approach to ensuring quality and timeliness in programming deliverables.
✨Understand Regulatory Requirements
Familiarise yourself with FDA regulations and ICH guidelines related to clinical trial data reporting. Be ready to explain how you've adhered to these standards in your previous roles.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in statistical programming and how you overcame them, especially in a clinical environment.