The Unloved Child Podcast | Lane Sane – Biostatistics

In this episode of The Unloved Child Podcast, I’m joined by Lane Sane, Senior Director of Biostatistics at Inhibrx, Inc.

Lane brings 20+ years of experience as a lead statistician, including 16 years within CROs and experience across 75+ Phase II–III clinical trials in multiple therapeutic areas. He has also supported 60+ DMC meetings as an unblinded reporting statistician.

More recently, Lane spent over four years at Inhibrx, where he built a scalable Biostatistics department from the ground up and led the team responsible for delivering the statistical eCTD components for a BLA filing to the FDA in Q2 2026.

Drawing on his experience from both the CRO and sponsor sides, we discuss outsourcing versus building Biometrics internally — when each model makes sense, where scientific ownership should sit, and what can be lost when too much knowledge and responsibility sits outside an organisation.

We also explore the relationship between sponsors and CROs, knowledge retention, scientific decision-making, the value of an embedded Biometrics team, and how these relationships may evolve as clinical trials become increasingly complex.

🎙️ The Unloved Child Podcast — giving a voice to the functions behind successful drug development that don't always get the spotlight.

The Unloved Child Podcast | Daniel Sakya | Director of Statistical Programming at Neumora

What does a Director of Statistical Programming actually do, and how does statistical programming help bring new medicines to patients?

In this episode of The Unloved Child Podcast, we sit down with Daniel Sakya, Director of Statistical Programming at Neumora, to explore the world of statistical programming in drug development. Daniel shares the personal experiences that inspired him to pursue a career in the pharmaceutical industry, discusses how the profession has evolved over the years, and explains the vital role statistical programmers play in delivering high-quality clinical trial data to regulatory authorities.

Whether you're considering a career in biometrics, already work in clinical development, or simply want to understand how medicines make it from clinical trials to patients, this episode provides an insightful look behind the scenes of modern drug development.

• Daniel's career journey and what led him into statistical programming.
• How family experiences with illness inspired him to work in drug development.
• What statistical programmers do throughout the lifecycle of a clinical trial.
• The importance of CDISC standards and why data standardisation has transformed the industry.
• What goes into preparing regulatory submissions for the FDA, EMA, and other global health authorities.
• The programming languages used in clinical research, including SAS and R, and how they're applied.
• How the role of statistical programming has changed over the years.
• The future of statistical programming and emerging trends within the pharmaceutical industry.

🎙️ In this episode, we sit down with Doug Leonard, Senior Director of Statistical Programming at Beacon Therapeutics, for an insightful conversation about his 20+ year career in clinical data analytics, statistical programming, and leadership across the biotech and pharmaceutical industries.

Doug shares his experiences building programming organisations from the ground up, leading global teams, supporting major FDA submissions, and adapting to the rapidly evolving world of clinical research and statistical computing.

We discuss Doug’s career journey in statistical programming and biotech, how the landscape of programming and clinical data science is changing, leadership lessons from managing high-performing global teams, and the impact of AI, automation, and emerging technologies on the industry.

Doug also offers valuable advice for the next generation of statistical programmers and clinical research professionals, highlighting the importance of mentorship, adaptability, and continuous learning.

The conversation also explores Doug’s proudest career moments and his contributions to groundbreaking therapies and important regulatory milestones. He reflects on the future of statistical programming, the growing importance of innovation in biotech, and what professionals can do to build long-term success in a fast-moving industry.

Whether you work in SAS programming, biostatistics, clinical data management, biotech, or pharmaceutical research, this episode offers valuable career insights and leadership perspectives from one of the industry’s experienced professionals.

Follow for more conversations with leaders in biotech, clinical research, healthcare innovation, and statistical programming.

#StatisticalProgramming #ClinicalResearch #SASProgramming #Biotech #FDA #DataAnalytics #PharmaceuticalIndustry #Biostatistics #Leadership #CareerAdvice #BeaconTherapeutics #ClinicalData #HealthcareInnovation

🎙️ The Unloved Child | JCR CDM — Featuring Narayan Lebaka

In this episode of The Unloved Child, we sit down with Narayan Lebaka, Senior Director of Clinical Data Management at Cellectis, to explore the critical yet often overlooked role of data management in advancing life-changing therapies.

With over 25 years of experience in clinical data management and more than two decades in oncology, Narayan brings deep expertise across solid tumors, liquid tumors, CAR-T, and cell & gene therapy trials. Throughout his career, he has been recognized for delivering inspection-ready, high-quality data and for driving efficiencies across complex clinical trial processes, earning multiple awards at Bayer and Bristol Myers Squibb.

At Cellectis, Narayan is leading data management efforts focused on innovative therapies, particularly in liquid tumors, while working closely with the Chief Medical Officer to support the development of next-generation treatments.

In this conversation, we dive into the evolving role of clinical data management, the challenges of working in cutting-edge oncology trials, and how strong data leadership is helping to shape the future of biotech.

The Unloved Child is a series dedicated to highlighting the overlooked but essential functions within clinical research — the people and disciplines quietly powering breakthroughs in medicine.

🎙️ Real-World Data in Healthcare | Biostatistics & Data Science Careers | Podcast with Laura Fernandes

In this episode of our podcast, we sit down with Laura Fernandes, Senior Statistical Director at Verana Health, to explore how real-world data, biostatistics, and data science are transforming modern healthcare. From analysing large-scale healthcare datasets to generating real-world evidence, Laura shares how data is driving innovation across the pharma, biotech, and life sciences industries.

We also dive into the evolving role of statisticians and data scientists—how the field is changing, the growing importance of real-world evidence (RWE), and the key skills needed to succeed in today’s data-driven healthcare landscape.

For students and early-career professionals, Laura shares valuable advice on breaking into biostatistics and data science careers, building in-demand technical skills, and standing out in a competitive pharma and healthcare job market.

Whether you’re interested in biostatistics, real-world data, data science careers, or clinical research, this episode is packed with insights to help you understand the industry and grow your career.

🎙️ Biometrics in Drug Development | Biostatistics Careers & Data Science Jobs | Podcast with Jesse Thissen

In this episode, we interview Jesse Thissen, Head of Biometrics, to explore how biometrics, biostatistics, and data science are transforming drug development. Discover how data drives decision-making in clinical trials, the growing importance of statisticians in pharma and biotech, and what the future holds for careers in biostatistics and data science.

Jesse also shares practical advice for students and graduates looking to break into the industry, including the key skills employers are looking for, different career pathways, and how to stand out in a competitive data science and pharma job market.

In this conversation, we discuss what biometrics is and its role in clinical trials, how biostatistics impacts drug development, the evolving role of statisticians in pharma and biotech, the most important skills for careers in data science, statistics, and biometrics, as well as practical tips and career advice for graduates and entry-level candidates.

💡 Whether you're interested in biostatistics careers, data science jobs, pharma careers, or clinical research, this podcast is packed with insights to help you break into the industry and grow your career.

In this episode, we’re joined by Mike Olds, Head of Clinical Data Management, with over 15 years of experience overseeing end-to-end clinical trial data operations across global programmes.

Mike has led data management strategy from study start-up through regulatory submission, with deep expertise in SDTM, regulatory data delivery, biomarker integration, and complex end-to-end data flows. He previously served as Senior Director of Clinical Data Management at GSK, where he played a key role in optimizing processes and strengthening submission readiness.

Beyond the technical expertise, this episode shares Mike’s professional journey — the lessons learned along the way, the leadership principles that shaped his career, and his advice for the next generation entering clinical research and data management.

We discuss not only the operational side of drug development, but also the mindset required to grow, lead teams, and build a long-term career in life sciences.

This episode is essential listening for professionals in clinical data management, biometrics, regulatory operations, SDTM programming, and pharmaceutical development — especially those looking to build or advance their careers in the industry.

Subscribe for more conversations with leaders shaping the future of clinical research and life sciences.

Leadership in Biostatistics: Driving FDA Approvals in Gene Therapy and Clinical Research

In this episode, we speak with Srinivasa Reddy Mukkala, Vice President of Operations – Biostatistics and Statistical Programming at EPIS DATA, about the critical role of statistical leadership in regulatory success.

Srinivasa has contributed to multiple FDA approvals, including breakthrough gene therapies such as ZYNTEGLO for Beta-Thalassemia and LYFGENIA for Sickle Cell Disease. He also served as statistical programming lead for NUZYRA, an FDA-approved tetracycline-class antibiotic.

We explore:

• The role of biostatistics and statistical programming in FDA submissions

• Delivering regulatory-ready clinical trial data

• The complexity of gene therapy trials

• Leadership in biometrics and global operations

• Career progression from pharmacist to data science executive

• The future of clinical research, regulatory science, and data integrity

This conversation is essential listening for professionals in biostatistics, statistical programming, clinical data management, regulatory affairs, pharmaceutical development, and life sciences leadership.

If you are involved in clinical trials, gene therapy, FDA submissions, or biometrics strategy, this episode offers practical insights from someone who has helped bring transformative therapies to patients worldwide.

Subscribe for more conversations with leaders shaping the future of biostatistics, clinical research, and pharmaceutical innovation.

In this episode, Martin McTurk joins us to explore the evolving world of Clinical Data Management (CDM) and its growing impact on modern drug development.

As the Head of Clinical Data Management at MAC Clinical Research, Martin brings decades of industry experience across leading CROs and clinical trial organisations. We discuss how clinical data management has transformed over the years, the increasing role of AI in clinical trials, and the therapeutic indications that are becoming more prominent in today’s development landscape.

Martin shares valuable insights into leadership in biometrics, building high-performing data teams, and delivering high-quality clinical trial data in an increasingly complex regulatory environment.

If you're working in clinical research, data management, biometrics, or pharmaceutical development, this conversation provides practical insights and forward-looking perspectives on where the industry is heading.

Martin’s journey through the clinical research industry is one worth hearing — and we’re delighted he shared it with us.