During my training at The University of North Carolina at Chapel Hill Department of Biostatistics, I gained a solid foundation in statistical theory and methods. I also worked at the Lineberger Comprehensive Cancer Center as a graduate research assistant. It all felt solid until I started my first real job. Reality hit.
I quickly found myself in the middle of oncology trials feeling unprepared to handle their real-world complexity. Despite my excellent graduate school preparation, the trials were unfamiliar and full of nuances I hadn’t seen before. My experience in a cancer center helped, but I felt like I was in a completely different world.
Back then, I wasn’t alone. Many had gone through rigorous academic programs, yet had limited exposure to the messy, uncertain, and highly regulated environment of actual clinical trials. It wasn’t until I began working hands-on with live studies that I started to understand just how much more there was to learn.
In those days, clinical trials weren’t yet seen as a core part of graduate biostatistics training. Today, things have changed, and many biostatistics programs do offer some exposure to clinical research. Yet, even now, the leap from academic training to real-world trials remains significant.
This may be especially true for trainees from statistics and data science departments who are interested in starting their careers in the clinical trial field, such as at academic medical centers, contract research organizations, or pharmaceutical companies. Limited exposure to clinical trials during their training will affect their ability to pursue these opportunities. Meanwhile, clinical trials, themselves, are becoming increasingly complex, highly regulated, and multidisciplinary.
Statisticians entering the field must be able to make important contributions from day one. We owe it to our community to better prepare them for that transition.
That’s why I’m excited to share one of this year’s ASA presidential initiatives: the development of the Clinical Trials Certificate Program. This program is designed to equip statisticians, biostatisticians, and data scientists with the specialized knowledge and practical experience they need to thrive in clinical research environments.
Why This Program? Why Now?
Statisticians play a central role in clinical research. We design studies, guide interim decisions, analyze outcomes, and help interpret results. But becoming a confident, effective clinical trialist usually doesn’t follow a clear path. It’s mostly learned through hands-on experience, guidance from mentors, and lessons picked up along the way. That process is valuable, but it doesn’t work the same for everyone, and it can be hard to navigate. We need a more structured way to support statisticians and data scientists who want to move into this area.
The new certificate program looks to bridge the gap between statistical training and clinical research practice. The goal is not to replicate academic degree programs but to complement them. Whether you’re a recent graduate, a mid-career professional looking to switch paths, or an academic researcher looking to collaborate on clinical trials, this program will provide the tools and experience you need to move forward with confidence.
Program Overview
The Clinical Trials Certificate Program will be a comprehensive, practice-oriented training experience. It will cover the following foundational and applied topics relevant to today’s trial landscape:
- Trial Design: Exposure to common and advanced trial designs, including adaptive trials, basket/umbrella trials, and platform studies
- Data Management and Infrastructure: An overview of systems, standards, and data flow processes in clinical studies
- Statistical Analysis Plans: Training in the development and implementation of SAPs, including protocol review and alignment with regulatory expectations
- Regulatory Frameworks: Understanding the rules and standards governing clinical research (with guidance resources from the FDA and other regulatory bodies)
- Team Science and Communication: Emphasis on communication, leadership, and collaboration skills, which are essential for statisticians in multidisciplinary teams
Participants will also engage in a capstone practicum, a hands-on experience working with real-world clinical trial data and challenges, in partnership with academic or industry collaborators. At the end of the program, they will present their work to a panel of experts.
Program Requirements
To receive the certificate, participants will have to do the following:
- Attend at least 85% of instructional sessions
- Engage in weekly problem-solving activities
- Complete all assigned readings and preparatory materials
- Demonstrate ability through milestone projects
- Complete a capstone practicum based on real trial data
- Present findings and recommendations to clinical research experts and faculty
The commitment will be significant, but so will the reward! Participants will finish the program with a stronger understanding of clinical trials, practical tools they can use on the job, and a network of peers and mentors.
Who Should Participate?
This program is designed for quantitatively trained individuals with a graduate degree in statistics, biostatistics, or data science who are looking to do the following:
- Enhance their qualifications for roles in pharmaceutical companies, contract research organizations, or academic medical centers
- Transition from other sectors (e.g., tech, finance, general research) into clinical trials
- Gain the experience and vocabulary needed to lead or contribute meaningfully to clinical studies
By broadening the pipeline into clinical research, we hope to foster a more inclusive and diverse clinical trials workforce, one that reflects the strengths and interests of our broader ASA community.
The Team Behind the Program
This initiative wouldn’t be possible without the leadership of an outstanding working group of experts, including the following:
- Lisa LaVange – An emeritus professor at UNC-CH and former director of the FDA Office of Biostatistics. Her regulatory expertise and academic leadership bring a crucial perspective.
- Amarjot Kaur – Executive director of clinical biostatistics and research decision sciences at Merck Research Laboratories. She has rich expertise and extensive experience in clinical trials, including immunotherapy trials.
- Antje Hoering – President and CEO of the Cancer Research and Biostatistics Foundation, with decades of experience in trial design and collaborative research.
- Nolan Wages – Director of the Biostatistics Shared Resource at the Virginia Commonwealth University Massey Cancer Center and a leading voice in early-phase trial design and education.
- Donna LaLonde – ASA associate executive director. She has been organizing and building the framework of this program.
LaVange expressed why she thinks this program is so exciting from her perspective:
Our obligation is to be vocal advocates for sound methodology at every decision point because the difference between a well-designed trial and a flawed one can literally be the difference between life and death for future patients. The proposed certificate program will help bridge a critical gap, providing statisticians with the skills needed to navigate the complex intersection of statistics, medicine, and regulation.
Together, they are shaping a curriculum that balances rigor, relevance, and realism. The program will reflect the demands and opportunities of clinical trial work today.
The ASA’s Role and Vision
At the ASA, we believe in supporting our members not only as scholars but also as practitioners and leaders. This program is part of a broader vision to create flexible, high-impact professional development opportunities that respond to evolving needs.
I also see this as an opportunity to strengthen our connection with key sectors, particularly the pharmaceutical and biotech industries, which are eager for statistical talent that is both technically strong and clinically literate. By providing targeted, high-quality training, the ASA can help close the preparation gap and raise the profile of statisticians as indispensable clinical partners.
Looking Ahead
The program is still under development, with a pilot expected in 2026. The working group plans to engage with academic departments, industry stakeholders, and ASA sections to ensure broad relevance and support. We hope to offer both live sessions and recorded content to accommodate different learning styles and time zones.
As we move forward, we welcome your input. What challenges have you faced when transitioning into clinical trial work? What topics or skills do you wish you had learned earlier? Send them to me. Your insights will help make this program stronger.
This initiative is personal for me. I remember what it felt like to step into clinical trials without a map. I want today’s statisticians to walk in more prepared, more confident, and more connected.
Let’s build that future together.
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