T2501 - Clinical Statistical Programmer (temporary 12 months contract)

As a Clinical Statistical Programmer at Debiopharm, your main responsibilities will include providing programming input for clinical trial databases and the Statistical Analysis Plan (SAP). You’ll develop and validate statistical programs that generate analysis datasets, tables, figures, and listings, and participate in creating specifications for these outputs. Moreover, you will collaborate with study teams to ensure compliance with Good Clinical Practice and handle ad-hoc programming requests to support internal and regulatory needs.

To qualify for the Clinical Statistical Programmer role at Debiopharm, candidates should possess a Master’s degree in computer science, statistics, biostatistics, or a related field. A minimum of 3-5 years of experience in statistical programming within clinical trials in the pharmaceutical industry or CRO is essential, along with strong proficiency in SAS programming. Familiarity with CDISC standards and a solid understanding of clinical trial data are also required.

At Debiopharm, Continuous learning and career growth are fundamental parts of our ethos. We offer various opportunities for our Clinical Statistical Programmers to deepen their understanding of statistical methodologies and the pharmaceutical landscape through ongoing training and cross-functional collaboration. This exposure not only enhances their skill sets but also offers pathways for career advancement within the company, allowing you to stay at the forefront of scientific innovation.

Clinical Statistical Programmers at Debiopharm primarily utilize SAS for data manipulation, statistical analysis, and reporting. Additionally, familiarity with software that supports data management as well as visualization tools may be beneficial. Being adaptable and willing to learn new technologies is also encouraged to keep up with evolving industry standards.

At Debiopharm, the work environment for Clinical Statistical Programmers is collaborative and innovative. Teamwork is heavily emphasized, ensuring everyone works towards shared goals in fighting against diseases. You will enjoy a mix of remote and on-site work, allowing you to maintain a healthy work-life balance while participating in exciting projects. The culture is inclusive, promoting entrepreneurial thinking and continuous improvement, making it a fulfilling place to grow your career.

In preparation for this question, think about specific projects you’ve worked on using SAS in the context of clinical trials. Highlight your proficiency in creating datasets, generating statistical reports, and manipulating data. Share particular challenges you faced and how you resolved them, focusing on the successful outcomes of your programming efforts.

When asked this question, discuss your understanding of Good Clinical Practice (GCP) standards and how you apply them in your programming tasks. Provide examples of how you’ve ensured that your programming outputs align with GCP guidelines, emphasizing the importance of quality control and documentation in your processes.

Reflect on a situation where you worked within a cross-functional team. Detail your role as a Clinical Statistical Programmer, and highlight how you communicated and addressed challenges with other stakeholders. Sharing a successful project outcome will illustrate your teamwork skills effectively.

Share your validation process, which could include peer review, creating test cases, and conducting thorough checks to ensure accuracy. Explain how you document the validation process and the importance of maintaining compliance with industry standards in your work.

Discuss your time management techniques and prioritization strategies, particularly in high-pressure environments. Provide examples of projects where you successfully met deadlines without compromising quality, reaffirming your commitment to the study objectives and patient safety.

When addressing this question, link your career choice to your passion for innovation in healthcare and your desire to improve patient outcomes. Mention specific experiences, such as projects that fueled your enthusiasm for combining programming with clinical research.

Demonstrate your proactive approach to lifelong learning by discussing the resources you utilize to stay informed, such as attending workshops, following leading industry publications, and being part of professional networks in clinical programming and biostatistics.

Explain the importance of attention to detail in your work, especially in relation to regulatory compliance and the accuracy of data reporting. Share techniques you use to maintain focus and ensure quality in your programming tasks, discussing any tools or processes that assist you in this regard.

Talk about the protocols you follow when handling regulatory inquiries and how you ensure that your data and programming outputs are compliant with the necessary guidelines. Mention your experience in providing document support during audits and inspections as a key aspect of your approach.

Provide an overview of the statistical methods you’ve utilized in your previous roles, mentioning the context in which you applied them. Highlight your comprehension of the methodological foundations behind these techniques and how they relate to the objectives of clinical trial design.