The Effective Statistician - in association with PSI

Interview with Rachel Tham What You’ll Learn: ✔ Why “index date” is more complicated than it sounds ✔ Common mistakes around exposure definitions ✔ The importance of understanding how RWE data is generated ✔ What programmers should know about timing, variables, and algorithms ✔ Why project management in RWE must be iterative and stakeholder-driven ✔ Key terminology pitfalls that can trip up even experienced professionals ✔ How data issues like duplicates, implausible values, and partial dates impact analyses ✔ Best practices for communication, timelines, and managing expectations in RWE projects Why You Should Listen: If you're working in real-world evidence or thinking of transitioning from clinical trials, this episode is packed with practical advice to help you avoid common mistakes and set your projects up for success. Rachel shares from her own hands-on experience—starting from data management and programming to leading statistical analyses in RWE. Alexander and Rachel also highlight real-world data quirks that no textbook prepares you for, making this episode an essential resource for statisticians, data scientists, and healthcare researchers alike. Links: 🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician. 🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills. 🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine. 🔗 PSI (Statistical Community in Healthcare) – Access webinars, training, and networking opportunities. If you’re working on evidence generation plans or preparing for joint clinical advice, this episode is packed with insights you don’t want to miss. Join the Conversation:Did you find this episode helpful? Share it with your colleagues and let me know your thoughts! Connect with me on LinkedIn and be part of the discussion. Subscribe & Stay Updated:Never miss an episode! Subscribe to The Effective Statistician on your favorite podcast platform and continue growing your influence as a statistician.

Manjari Narayan, a speaker at the Effective Statistician Conference 2024, dives into the transformative impact of AI on biotechnology and drug development. She discusses the untapped opportunities for statisticians to innovate before clinical trials and the challenges posed by AI-guided experiments. Manjari emphasizes the importance of experimental design, decision-making, and the need to rethink biomarker discovery. She also encourages embracing generalism and risk-taking for career growth, highlighting strategies for expanding professional opportunities.

Keynote by Prof. Tim Friede | The Effective Statistician Conference 2024 What You’ll Learn: ✔ When and how to combine RCTs with real-world data (RWD) ✔ The CJD study: lessons from combining registry and trial data ✔ Hierarchical Bayesian meta-analysis and shrinkage estimators ✔ Robustness of these approaches in the face of heterogeneity ✔ Practical coding tips using the bayesmeta R package ✔ Design strategies for prospective data integration ✔ Regulatory perspectives on RWD-supported evidence Why You Should Listen: If you’re working in rare diseases, pediatrics, or situations where large-scale RCTs are not feasible, this episode offers practical tools and methodological clarity. Tim’s approach helps statisticians create more informative and reliable evidence from limited data—crucial for both research impact and regulatory engagement. Resources & Links: 🔗 Bayesmeta R package 🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician. 🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills. 🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine. 🔗 PSI (Statistical Community in Healthcare) – Access webinars, training, and networking opportunities. If you’re working on evidence generation plans or preparing for joint clinical advice, this episode is packed with insights you don’t want to miss. Join the Conversation:Did you find this episode helpful? Share it with your colleagues and let me know your thoughts! Connect with me on LinkedIn and be part of the discussion. Subscribe & Stay Updated:Never miss an episode! Subscribe to The Effective Statistician on your favorite podcast platform and continue growing your influence as a statistician.

Sebastian Schneeweiss, a Harvard Medical School professor specializing in medicine and epidemiology, shares insights on emulating randomized trials with real-world data. He discusses the motivation behind this approach, emphasizing its significance for regulatory-grade evidence. Topics include the challenges of data quality and adherence, use cases for real-world evidence in expanding treatment indications, and the innovative ‘Benchmark-Calibrate-Extrapolate’ strategy. This conversation is a must-listen for those in biostatistics, epidemiology, and healthcare innovation.

Discover the transformative power of genuine networking, driven by curiosity rather than small talk. Learn to set clear intentions for building meaningful connections at events. Uncover myths that may hold you back and develop strategies to overcome them. Get practical advice specifically for conference attendees, ensuring you network with confidence. Embrace the idea that authentic relationships with peers and mentors can unlock unexpected career opportunities and foster personal growth.

Emma Crawford, an autism advocate and leader in workplace inclusion, shares personal insights into navigating autism in professional settings. She emphasizes the critical need for inclusive work cultures and proactive leadership that seeks feedback. Topics include embracing neurodiversity, the role of technology in accessibility, and the importance of kindness in leadership. Emma calls for a shift in attitudes towards disability, encouraging workplaces to become environments where everyone feels empowered to express their needs.

Anna Forsythe, a Pharmacologist and healthcare economist, is the founder of Oncoscope, which automates systematic literature reviews to enhance cancer treatment decisions. In this conversation, she explores how daily updates in literature reviews can revolutionize oncology. Anna discusses the balance between innovation and clinical responsibility, and the introduction of AI in improving SLR accuracy. She shares insights on making cancer data accessible to patients and her commitment to altruistic ventures that prioritize patient care over profit.

Join Pavel Mozgunov, a group leader at the MRC Biostatistics Unit, and Julia Geronimi, a principal translational statistician at Servier, as they delve into innovative methodologies for biomarker analysis. They discuss how to effectively pre-specify analysis strategies, enhance predictive modeling, and tackle the challenges of small sample sizes. The conversation unpacks the complex distinctions between prognostic and predictive biomarkers while advocating for structured approaches to optimize clinical trial outcomes. Get ready for fresh insights into the future of biomarker-based trials!

Yannis Jemiai, Chief Scientific Officer at CITEL with 20 years in the field, and Flaminia Chiesa, a statistician with a focus on leadership and innovation, delve into the evolving role of statisticians. They discuss how AI and real-world data are transforming clinical trials and the necessary skills statisticians must develop to remain relevant. The conversation highlights the importance of interdisciplinary collaboration and offers insights on building confidence in leadership roles as data science becomes more strategic.

Katrin Kupas, a seasoned Director for Real-World Evidence with a decade of expertise in Health Technology Assessment, shares fascinating insights on integrating RWE with Joint Clinical Assessments. She emphasizes the importance of early evidence planning and when RCTs might fall short, making room for RWE. The conversation reveals the intricacies of indirect comparisons and the risks of non-randomized studies. Katrin also highlights the ROBINS-I tool for effective bias assessment, offering listeners actionable strategies to enhance their evidence generation plans.