Ryoto Ozaki works as a statistical analyst, designing clinical studies.

He has always loved mathematics and was fascinated by statistics in his university days, and he wanted to find a job where he could work in this field. ‘In my job search, I focused on pharmaceutical companies, where I could be involved in operations as a specialist statistical analyst and where I would have opportunities to keep enhancing my expert skills. In particular, when I was studying mathematical statistics at graduate school, I had met people working in statistics at Chugai Pharmaceutical at academic conferences and other forums quite often, and I gained the impression that this was a company that also places importance on industry and research activities. I had also heard that many Chugai Pharmaceutical employees attended graduate school and obtained their doctorates and that this was actively encouraged by the company. I felt that I would be able to achieve the kind of career I wanted, so I submitted my application to Chugai Pharmaceutical.’

After joining the company, Ozaki was assigned to the Biometrics Department in the Clinical Development Division, where he was mainly engaged in the statistical analysis of clinical studies. ‘A clinical study is an important development process for evaluating the efficacy and safety of candidate agents by administering them to humans. To clarify the efficacy and safety of the candidate agents, we consider a range of factors when designing clinical studies. They include how long the candidate agents should be administered for, what data we should aim to obtain from which subjects when conducting the study, and what the appropriate statistical techniques should be. I then analyze the results of the clinical study, prepare a clinical study report with appropriate statistical interpretations, and handle applications to the regulatory authorities. In fact, statistical analysts such as myself are involved in the entire span of the clinical development process from start to finish.’

The ability to insist on discontinuing development with conviction

Chugai Pharmaceutical is constantly rolling out various drug development projects. Experts in statistical analysis like Ozaki are assigned to individual projects as statistical analysts and play an important role on the team. This is a constantly evolving field, so Ozaki is constantly on the lookout for new developments to ensure that he is not left behind. He says it is fun thinking about how he will incorporate the knowledge and insights thus gained into his work. On the other hand, there is no guarantee that clinical studies will always produce good results. If the results are not satisfactory, a decision to discontinue the development may need to be made. Ozaki believes that this is the moment when his true worth as a statistical analyst is put to the test.

‘I want to be the kind of specialist statistical analyst who, when the results of the study are unfavorable, can be confident about asserting that there is no evidence that a particular candidate agent will lead to the treatment of patients. To do so, I need to design clinical studies accurately and collect the data needed for evaluation. If the study design veers off course and we only collect and analyze unnecessary information, we may misjudge the intrinsic potential of the drug, and I would feel guilty toward the subjects who cooperated with the clinical study. More importantly, it would be a waste of resources that would be better used for the sake of patients. I am deeply conscious of this point as I engage in my work.’

A wealth of opportunities to gain intellectual stimulus outside the company

Ozaki says that, as he had hoped before joining the company, Chugai Pharmaceutical has given him many opportunities to enhance his specialist skills of his own volition. In fact, with the company’s approval, he is now studying in a doctoral course at graduate school outside of work hours. ‘In my doctoral course, I am working on the research of survival analysis, which is a field of clinical statistics. I really enjoy it because I am working on a theme that personally interests me, so I have no trouble at all pouring my own resources into it. While attending graduate school, I also participate in activities related to data science in clinical development conducted by industry associations. In my third year at the company, my boss asked me if I was interested in participating in this kind of activity, and because I didn’t want to miss the opportunity, I accepted the offer and I am now working on an activity on behalf of Chugai Pharmaceutical.’

As part of this organization’s activity, a symposium was held on the theme of “causal inference,” which is a hot topic in the field of drug development data science, and Ozaki was given the opportunity to deliver a presentation. His presentation materials have since been published on the organization’s website. ‘Working on industry association activities has expanded my world significantly, and I find interacting with specialists from other pharmaceutical companies to be very stimulating.’
Ozaki says that Chugai Pharmaceutical is a place where people like him will be able to satisfy their intellectual curiosity immensely. By improving his knowledge and skills in statistical analysis even further, Ozaki hopes to become an essential professional.

*The contents of this article, and the divisions that the people featured in this article belonged to and the names of those divisions are current as of the time of the interview.