The Effective Statistician - in association with PSI

Interview with Annie Wright Key points: Environmental Impact Carbon Footprint Drivers Decentralized Trials Study Design Simplification Protocol Amendments Waste Management Greener Initiatives Technology Adoption Awareness and Collaboration Call to Action CO2 Calculators Public and Private Collaboration Clinical trials play a vital role in advancing healthcare, but their environmental impact cannot be ignored. By rethinking how we design and operate trials, we can reduce carbon emissions, streamline processes, and contribute to a greener future. Whether it’s embracing decentralized trials, simplifying study designs, or engaging in sustainability initiatives, we all have a part to play. If this episode inspired you, share it with your friends and colleagues. Let’s spark conversations about making clinical research more sustainable and work together to create positive change. Don’t forget to listen, reflect, and take action—every step counts!

Kaspar Rufibach, an influential statistician specializing in survival analysis, dives into the complexities of non-proportional hazards. He discusses the vital differences between hazard functions and survival functions while emphasizing their clinical relevance. The conversation highlights effective communication strategies for non-statisticians and the importance of innovative data visualization. Kaspar also explores challenges in trial design and suggests alternatives to traditional effect quantification methods, all aimed at enhancing the understanding of treatment dynamics in clinical settings.

Interview with Aziza Yormizaeva and Klaus Breuer Key points: Leadership: Building trust, inspiring growth, and prioritizing collaboration. Mentorship: Klaus guiding Aziza to discover her passion for statistics. Professional Growth: Empowering team members to learn and succeed. Authenticity: Honest communication and standing by data-driven insights. Collaboration: Creating win-win situations for individuals and the organization. Trust-Building: Establishing credibility through support and training. Empowerment: Teaching others to leverage tools and make informed decisions. Sustainable Value: Creating systems that deliver results even in your absence. Continuous Learning: Both leaders and team members growing together. Personal Growth: Developing not just careers, but individuals as a whole. This episode highlights the transformative power of authentic leadership, trust, and mentorship in driving both personal and professional growth. Aziza and Klaus show us how fostering collaboration and empowering others can create lasting value for individuals and organizations alike. Their story is filled with practical lessons and inspiring insights that can help you on your own journey as a statistician, leader, or team member.

Interview with Oscar Segurado, MD PhD Key points: Gene Therapy Uniqueness: Differences from traditional drug development Safety & Dosing: Single-dose approach, safety considerations Statisticians' Role: Essential contributions in planning and analysis Guest Background: Oscar’s expertise in academia, med tech, biopharma, Humira development Clinical Development: Phases from trials to commercialization Rare Disease Focus: Hemophilia A, spinal muscular atrophy Challenges & Opportunities: Unique clinical and statistical challenges Future of Medicine: Insights into advancements in gene therapy Oscar’s expertise sheds light on the unique challenges and groundbreaking possibilities in this field, highlighting the critical role that statisticians and data scientists play in advancing these therapies. If you found this episode insightful, I encourage you to listen in full and share it with colleagues, friends, or anyone interested in the future of healthcare. Let’s spread the word on how statistical expertise is driving the next frontier in medicine—tune in, learn, and pass it on!

Avery McIntosh, a statistician at Pfizer specializing in gene therapy, and Oleksandr Sverdlov from Novartis, focusing on neuroscience, share their insights into the innovative world of gene therapy. They discuss the evolution and breakthroughs in the field, like CRISPR technology, while addressing the ethical challenges of clinical trials. Their experiences highlight the important role statisticians play in navigating regulatory demands and advancing treatment solutions. Listeners will appreciate the blend of technical expertise and compelling storytelling.

In this engaging discussion, Carrie Li, a physician and statistician with over 13 years in the pharmaceutical sector, shares her insights on Clinical Development Plans (CDPs). She highlights the importance of early decision-making and cross-functional collaboration among clinical, commercial, and regulatory teams. Carrie elaborates on the differences between big pharma and startups, adaptive design strategies, and regulatory engagement with the FDA and EMA. Listeners will gain practical tips on balancing scientific rigor with business goals to advance drug development.

Pietro Mascheroni, a physicist at Beringer Ingelheim specializing in machine learning and AI, dives into the transformative power of large language models (LLMs) in pharmaceutical research. He discusses their practical applications like document retrieval and data exploration. Pietro emphasizes the necessity of human oversight to ensure accuracy, while explaining how LLMs enhance team communication and collaboration. He highlights the challenges of validating AI models and the evolving capabilities of these technologies, reinforcing their potential to streamline workflows.

Interview with Swarna Khare Key points: Expanding Careers: Statisticians moving beyond traditional statistics roles. Transferable Skills: Data interpretation, strategic thinking, communication. Career Transition: Swarna’s journey from statistician to strategic roles. Broader Impact: Using statistical skills in non-technical positions. Practical Advice: How statisticians can leverage their expertise. Opportunities: New career paths and roles outside statistics. Actionable Insights: Steps for statisticians to broaden their horizons. In this episode, Swarna’s journey shows how statisticians can successfully move beyond the traditional boundaries of their roles and make a broader impact in various industries. If you're looking to take your skills to the next level and explore new career opportunities, this episode is full of valuable insights and practical advice.

Interview with Taina Pereenniemi Key points: Introduction to Notion Taina’s Journey Key Features of Notion Collaboration & Integration Productivity Benefits Generative AI Replacing Other Tools Getting Started with Notion Paid Features Conference Workshop Taina shares invaluable tips on getting started with Notion and highlights its potential to replace multiple tools while simplifying your personal and professional life. Don’t miss out—tune in to the episode now and discover how you can start using Notion effectively. And if you found this episode helpful, be sure to share it with your colleagues and friends who could benefit from optimizing their productivity!

Interview with Daniel Sabanés Bové Key points: Statisticians and software engineering: Learning from software engineering practices to improve statistical work. Daniel Sabanés Bové career path: Transition from biostatistician at Roche to data scientist at Google, and return to healthcare. Software engineering principles: Importance of clean coding, automation, and collaborative development. Coding in the pharma industry: How tech practices can enhance pharmaceutical statistical work. Open-source tools: Utilizing tools like Git and automation workflows to improve efficiency. Automation: Streamlining repetitive tasks to focus on value-adding work. RCONIS: Daniel’s new consulting venture combining statistics and software engineering. Daniel shows how software engineering principles can transform the way statisticians work, offering practical tips to improve coding skills and workflow efficiency. If you're looking to boost your productivity, adopt better coding habits, or learn more about the intersection of tech and pharma, this conversation is full of valuable insights. Listen to the full episode now, and if you find it helpful, share it with your friends and colleagues who can benefit from these ideas. Let’s work together to improve and innovate!