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Career Perspectives: A Conversation with Emily Woolley

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In this latest edition of our Career Perspectives series, we had the privilege of interviewing Emily Woolley, Senior Director of Biostatistics at Axio, a Cytel company, residing in Oregon, USA. With over a decade of experience in clinical trial statistics and serving as an independent statistician for numerous trials, Emily brings a wealth of expertise and insights. In this interview, Emily talks about her career progression and the intricacies of her role as a leader in the Data Monitoring Committee (DMC) domain. She shares her approach to building strong client relationships and mentoring team members, emphasizing the importance of personal and professional growth in the dynamic landscape of biostatistics.

Can you describe your journey into biostatistics and your career progression up to your current role?

I joined Axio Research, LLC in June 2015 as an office-based Biostatistician in Seattle, WA. What differentiated Axio was that I wanted to work for a small company where I could expand my role beyond technical responsibilities and where I could see myself staying for 3–5 years.

At the four-year mark, I led projects as an independent statistician, oversaw biostatistics for Axio’s clinical study reporting, served as a line manager, and showcased the business at conferences. That year, Cytel acquired Axio. I believed this change would provide additional opportunities.

Over the past five years, I have grown into a leadership role within the DMC business by successfully adapting to its evolving needs. Currently, I lead the global DMC biostatistics team.


You’ve served as the DMC independent statistician on 50+ clinical trials in different therapeutic areas. Could you share some insights into your experience in this role? What were some key challenges, and how did you overcome them?

To be successful as an independent statistician, you must balance technical expertise with thoughtful client communications. As a Statistical Data Analysis Center, Axio delivers services that sponsors cannot check or see themselves. Such services include creating closed DMC materials and hosting closed-session DMC meetings that enable the DMC to make an informed recommendation. All interactions with sponsors and DMCs are opportunities to show our competence and build trust.

I enjoy the challenge of teaching others how to write tricky communications. As an independent statistician, your audience is rarely another statistician. Even when communicating with fellow statisticians, they are rarely unblinded. DMC members engage in a study several times a year. However, sponsor team members engage with their study daily, and the DMC’s role is one small piece of executing a study. Balancing these perspectives with the overarching premise of “what does the DMC need to make an informed recommendation” requires creative problem-solving.


How do you build and maintain strong client relationships in your role? Can you share any recent accomplishments or success stories?

In the DMC space, client relationships require two dimensions: 1) a relationship with the DMC, who is the ultimate client, and 2) a relationship with the sponsor, who is the traditional client.

Our approach with the DMC focuses on delivering what the DMC needs when the DMC needs it so they can fulfill their obligations outlined in the DMC Charter. This includes creating and delivering materials, offering guidance through the materials in closed-session discussions, addressing ad hoc inquiries, and advising the DMC when required to help them reach a consensus recommendation.

With sponsors, we prioritize consistent delivery and proactive communication regarding timelines. My role is to equip our teams to build these relationships, guide and support them as needed, and advise on client-focused trends within the organization.


Could you discuss your experience with adaptive, Bayesian, and other innovative trial designs? What are your thoughts on the future direction of these methodologies?

Given the size of our DMC business, we see a wide range of trial designs. While we see more novel designs emerging, registrational trials tend to employ more conservative designs. I expect we will continue to see more novel designs along with traditional designs as the use of DMCs is constantly expanding. We are seeing more early futility analyses in traditional group-sequential designs, which is encouraging from an ethical perspective.


What strategies do you use to mentor and develop your team members, particularly in statistics and business management?

Our DMC group has specific onboarding and training materials for individual contributors and pairs all new employees with a mentor. Ongoing project assignments and interactions offer the greatest opportunities for technical and business growth. We are incredibly intentional with project staffing to expose people to various statistical methods, sponsors, and DMC material creation models. We invest time talking to individual contributors and line managers to evaluate what is necessary for our employees to succeed. We also facilitate connections between individuals seeking assistance, helping them establish internal support networks.


What would you advise aspiring biostatisticians looking to advance their careers into leadership roles similar to yours? Are there specific skills or experiences you believe are crucial for success in this field?

Personal and business growth can be mutually beneficial. Serve the business so the business can serve the populations who benefit from the treatments in development. Serving the business provides opportunities to learn and gain experience.

Our project environment provides exposure beyond the technical realm and includes project and financial management. While these tasks are not statistical, they are essential for professional development.

It is important to seize and excel in new opportunities that arise. Such opportunities can broaden or deepen our knowledge and may require redirecting efforts. While new opportunities always appear to be more work, simply completing the tasks is not enough. It is crucial to approach tasks with personal integrity, communicate your progress and completion status, and add your insights about how the task relates to the business.


What is the most rewarding aspect of working in this industry and at Cytel?

The people!


Lastly, what are your main interests outside of work?

I live in sunny Bend, OR, on a small farm with my horses and dogs. With my horses, I enjoy dressage and trail riding.


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