I am really passionate about leadership and Claude Petit is also passionate about building leaders and being an effective leader. Together, we will share with you how to become a statistical leader, how to build an organization of leaders, her very interesting leadership journey, and what it actually means to be a Statistician.
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Claude Petit, PhD
She earned her Phd, concurrent with a medical degree in 1999 in the field of Biostatistics from the University of Kremlin Bicêtre (France) where she studied Bayesian methods applied to clinical trials, specifically involving the study and treatment of schizophrenia.
She served as Adjunct Professor in Mathematics & Statistics at the University of Grenoble, Medical University of Paris, and Ecole Nationale de la Statistique et d’Administration Informatique (ENSAI), until her arrival in the US in 2007. She has been a lecturer at the Yale School of Public Health since July 2012.
Extensively published, Dr. Petit has worked at several CROs and Pharma companies since 1994, increasing her leadership responsibilities. She joined Boehringer Ingelheim in 2004 and was the US VP Biostatistics and Data Sciences in Ridgefield CT until 2021. During this time, she was involved in multiple global submissions, interacting with the FDA through NDA meetings, Advisory Committees and inspections. Eternal learner, Claude always demonstrated a strong passion for leadership, collaboration and innovation. In September 2021, she became a certified executive coach and founded Creating & Coaching Essential Leaders, LLC focusing on leadership & career development, through a transformative and inspiring journey in a trusting and forward-thinking environment. In October 2021, Dr Petit started as the Global VP Biostatistics and Statistical Programming at Astellas leading a team of Statisticians and Statistical Programmers in US, Japan and China. Claude’s topics of interest are patient’s diversity and inclusion in clinical trials, Real world data and Data Monitoring Committees.
In 2022 in the US, 1700 people will lose their battle against cancer every day.
25 years ago my dad was one of them.
This is why after earning my PhD in Biostatistics, I joined the Pharmaceutical Industry to bring my stone to clinical trials design and analysis. Lecturer at Yale School of Public Health for a decade and VP Biostatistics & Statistical Programming at Astellas, I am leading a global team of equally relentless Statisticians and Programmers in US, Japan and China.
Eternal learner, I have a passion for leadership, growth and teaching. In 2021, I became a certified Executive Coach and funded Creating & Coaching Essential Leaders, LLC to empower one woman at a time.
Transcript
Building Organizations of Leaders
Alexander: You are listening to The Effective Statistician Podcast, a weekly podcast with me, Alexander Schacht, and Benjamin Piske, designed to help you reach your potential lead, great science and serve patients without becoming overwhelmed by work. Today, we are talking again about leadership and about how we can build organizations of leaders and the big benefit of this so stay tuned with this discussion with Claude Petit.
Claude is a really interesting statistician, she has done some additional work on becoming a really good leader. And we will talk about this and her passion for building leaders and being an effective leader in the discussion today. You know, I’m really passionate about Leadership. That’s also one of the reasons why I have my leadership program, The Effective Statistician Leadership Program, together with Gary Sullivan. If you want to learn more about this then head over to our homepage.
Welcome to another episode of The Effective Statistician, today I’m talking with Claude Petit, how are you doing?
Claude: I’m doing very well.
Alexander: Very good. So we just had a little bit of an introductory talk, but for the listeners, can you explain a little bit what your career has looked like and then what you’re doing now?
Claude: Sure. So as I’m sure you can hear, you know that I don’t have an American accent so my career started in France. I actually moved to the U.S. 15 years ago with Boehringer Ingelheim, and my background is in statistics. I started as a Statistician a long time ago, and I’ve been working for different CROs and different pharma companies. And my Ph.D. was in Bayesian Statistics which at that time was very, very new, you know, it’s not anymore but that was very controversial when I did my Ph.D. and I remember this heated debate about Bayesian Statistics. So I spent 17 years at BI and then last summer, I changed jobs and in between jobs I decided to go back to school. So actually, I went back to the American University and became a certified coach, an executive coach. And I must say, I had a lot of fun doing that, you know, I never thought I would have so much fun going back to school.
And then in October, I started working again. And now the VP for Biostatistics and Statistical Programming at Astellas, so Astellas is in Chicago, but I’m still in Connecticut and I’m working remotely from home.
Alexander: Very good, that also means a one-hour time difference less to Europe, which I think is quite nice. But of course, the one-hour time difference in Japan is important for Japanese companies. So when you went back to a University, what made you go back there and become a coach and especially kind of, in terms of a coach about leadership?
Claude: Yeah. So, you know, first, I’ve always enjoyed learning new things and, you know I’m from France, I never went to school in the U.S. so I was very curious about the University system in the U.S. and I wanted to learn about it. And being a leader for me was all about
developing the people and taking care of them, and finding ways to motivate them and communicate with them. So I really thought, becoming a coach is actually a nice way to do that, to achieve that. And being a leader, I always thought I was coaching as well. I would define myself as a Leader and a Coach, but actually, when I did that training, I understood that I was more like a mentor rather than a coach, and being a coach is actually very difficult and very rewarding and that’s something that like everything else, you need to learn the techniques and you need to learn how to do it, to be good at it.
Alexander: And what’s more for you a Mentor versus a Coach?
Claude: Yeah, so the way I understand it is a mentor is, basically you tell people stories about what you’ve done and how you’ve done it, and maybe you try to inspire them, how they could lead your career or solve issues. Being a coach is very different, being a coach is really about helping people find the solutions themselves. So it’s a lot of asking questions and making people think and help them find the potential that they have, which is sometimes deep inside and help them find Solutions. So it’s very nice because I think it builds people for the long term to become independent and to find solutions, even when you’re not there anymore.
Alexander: I can completely see that and of course, if you have done it, been there it’s very easy to tell a story and show I’ve done that this way in the past. But that does not give a quick fix but it doesn’t necessarily help them to maybe develop other areas or go different paths that might be actually more successful and also kind of have their own mistakes and create their own stories.
That is very good. Speaking a little bit more about leadership, what actually is leadership for you?
Claude: Yeah, so for me, really being a Leader, the first thing is to create a safe space for the employee so that they can really give their best and feel like you have your back. And you’re going to be there to support them regardless of the outcome. And what’s important for me is that in the end people can reach their potential and they can develop themselves. And of course, it’s a win-win for the company and the employee. And that’s really what it is about. It provides a safe space and enough direction so that people know what they should do and they can really give their best.
Alexander: What is that safe space that you start with? Why is that so important? What does that achieve?
Claude: Well, I think if you’re not in a safe space, then you’re going to spend most of your time protecting yourself and making sure that nothing bad happens to you. And that’s not where you’re going to be Innovative. That’s not where you’re going to take risks. That’s not where you’re trying to be outside your comfort zone. It’s exactly the opposite, you’re going to keep doing the same things, again and again, the way you know it’s going to work you’re going to make sure that every step is covered. So most likely not try to accelerate anything or try anything new. And for me, that’s exactly the opposite of what we should be doing in the Pharma Industry.
Alexander: Yeah, so if there is no safe space, you make it safe yourself by playing by yourself, by doing exactly what you’re told by checking in on every step that you’re making, and always covering your back and never stepping out of line. How do you create that safe space?
Claude: Well, I think it’s really a matter of trust, it’s something that takes time for sure. And it’s really how you behave, I would say. It’s great to talk about something, it’s even better to demonstrate it. So it’s really how you’re going to react and how you’re going to be supporting your staff, when there are difficulties, how you’re going to coach them in order to find the right solutions. And I think it’s also a Company Culture, you know? And I’m very happy to work for Astellas because I think they have this culture, especially being a Japanese company, you know in Japan, it’s lifetime employment. So people join Astellas still and you’re very young, fresh out of school and they spend their whole life there. So it’s a big decision for them when they decide to work for such a company. And so the company in return is providing a safe space and a chance for employees to have a happy business life. So I think it’s very important to you to have that.
Alexander: Yeah, I agree that it is really important and I love that you started with trust, I completely agree. Trust is the fundament and if you show that you care for the people, that you have their back, you show your character. These are really important parts and also that you have the competence to coach them and to move them forward as the supervisor of fundamental things. And as you said, you can talk a lot, but what really changes the needle is when push comes to show how you act. Yeah, I find it interesting when people speak about communication, it’s so much about the words you say or the words you write. I think how you behaved is a much stronger communication signal than all those speeches that you do.
Claude: Yeah, I agree, and how you make people feel as well I think it’s very important. You know beyond words, we’re all humans and we all want to be recognized and valued for the work we do and respected. And I think that the way you make people feel is more important than anything else.
Alexander: Yes, very good. How do you make them feel valued and recognized?
Claude: Well, first, I really believe in constant feedback, so I don’t think that we should talk to people twice a year when they have a performance review. Hopefully, we can discuss this with them more often than that. So it’s really by providing the good and maybe the opportunity feedback as well that’s going to help them. And it’s also about you know, giving them the credit they deserve. So as a leader I’m not doing any work by myself anymore. So I always ensure that People understand who was behind the scene, who actually did the work, and who should be recognized for it. And it’s very important that people know that what they do is seen and understood.
Alexander: Yeah, there’s nothing worse than, as a supervisor taking the credits that belong to the team.
Claude: Yeah, absolutely.
Alexander: That completely destroys trust really fast, I completely agree. Feedback is also a really important point. How do you provide feedback? I think what I’m really struggling with is feedback in our remote settings. I love giving feedback but having the opportunity to observe behavior that I can give feedback about is not that of here. So of course, maybe I see something like an email or presentation or something like this, but of course, I don’t sit next to them to give some constant feedback all the time. How do you deal with that?
Claude: Yeah, so of course, it’s easier face-to-face. You know, like you would go to a meeting and right after the meeting, you would give like for two or three minutes you would give some quick feedback and that’s easy to do. Now you can’t do that anymore. So you have to find other ways, you know I do use IM a lot, so if we are in a meeting or at the end of the meeting, you can IM the people, of course, not trying to distract them when they are presenting but afterward. If it’s positive feedback, just a simple “That was fantastic! You did great.” People really like it. If it’s more constructive feedback, I think it’s better to have a discussion. So what I’m trying to do now is to have very quick meetings, like 5 minutes, 10 minutes, and as close as possible to the event. So you don’t want to give feedback three weeks later, I think that’s a little bit too long. So again I’m using the IM and you know saying “Hey when you have five minutes, just give me a phone call, and then we’ll discuss it.” I think that’s very efficient.
Alexander: Yeah, I also really love the phone call thing, the very quick thing to just say “Are you okay to get some feedback?” And then, you know, say, oh, you did this and that had this good impact all this bad impact. And I agree, it’s three to five minutes, it’s more about doing that consistently rather than you know doing it for sure not just once-twice a year.
Claude: Absolutely, and I’m the first one to recognize that getting feedback is not always easy, if it’s the positive feedback of course we love it. But constructive feedback, sometimes it’s a little bit more difficult to accept. So in return, I also want to show people that I’m very open to feedback myself, and if I do something wrong or something that could be done better, then own it, apologize for it or correct it and just move forward.
Alexander: Yeah, that’s a really good point. And I think that also shows if you have built trust with your people and you get these kinds of feedback then that is really something that helps you to adjust and to correct. And I have always been very open about these things and it has helped me quite a lot to improve, to adjust. And sometimes also possible to give certain kinds of additional background on things. Yeah. So maybe you didn’t communicate a decision clearly enough and why you have taken it that way. Maybe, the person didn’t understand because, from their point of view, it didn’t make sense, and I didn’t have the whole context. So people then question you and as you mentioned earlier about the Safe Space to call you out on it, that is really good. And it helps so much with company culture.
So If we think about ourselves as statisticians, why is it so important for us to be Leaders?
Claude: So I think that the way I see it and being a Statistician myself, I really think that decisions have unique skills in the Pharma Industry, and there is a lot we can do to help the other functions. First of all, I think that Statisticians are usually part of a core team and work
with different functions, Scientific, Non-Scientific, Medical, and Non-Medical. And I really think that they can be the bridge between all these different functions and make sure that there is good communication. But I think what Statisticians have is this ability to understand the context and to translate it into a scientific question or into a trial design, and they see what’s going to be needed to have the evidence in the end to draw a conclusion.
Alexander: Yeah, I think what we very often take for granted is our skill to conceptualize things, move it into some you know, data space, and to some study design data space, which we have learned over years, and years. And it’s kind of air that we breathe, we don’t kind of realize it and I think being aware of the strengths and utilizing it is really important.
Where do you see Statisticians typically struggle in terms of convincing others on their point of view in terms of these data things?
Claude: Well, I think unfortunately there is still sometimes the thinking that you call the Statistician when you have to write the statistical section in the protocol. So we are late in the game, which makes it very difficult for them to give input that will be impactful. So, I really hope this can change and I think statisticians have to fight to really have a seat at the table early on so that we can have a real impact. I think they also have to find a way to, you know, we all have these T-shaped skills. Okay, so we have very deep technical skills which obviously is part of a job but sometimes we also have to broaden a little the T and understand what the medical questions are to understand the disease., understand the patients, and how they feel? What’s meaningful for them? And I really think if statisticians could make that effort, sometimes to learn beyond the technical skills that would help them really be part of a development team and have a real influence on the drug development plan, which I think is where we should be spending our time. I understand, not just one child, but what is a strategy to get a drug approved?
Alexander: Yeah, what is the strategy to get approved? What are the internal processes? Yeah, I was very often able to drive things forward because I knew how to get things approved, yeah. Who to ask for? What are the committees? All these kinds of different things. Whereas the Physicians I was working with, were great from a medical point of view. But they had no clue in terms of how that runs within the business. And having this business know-how can give you a great advantage over others.
And that’s another point, and as you mentioned understanding the patient, understanding the regulatory landscape, understanding the HDA landscape, what will it take to get this product successful to the market? And what’s a competition that It will likely hit? Having these external views is also really important. So if we would have a Statistics Organization that would be full of these statistical leaders, these people that are both, you know, have a strong T both you know deep and wide in terms of knowledge and Leadership, what would that look like? What would be the success from an organizational perspective?
Claude: Well I think really, it’s so complicated to get a drug developed and approved, it is all about collaboration. So it is really all about people working together and complementing each other. So I think even Statisticians are there and can facilitate this communication and this dialogue. But that would make a big difference, even among the quantitative functions, I would say because now we have Biomarker Specialists, we have translational medicine, we have early statistics, late statistics. So I think it’s good to make sure that all these people work together and that they are on the same page as well.
And the other thing is, we’ve all been in that situation that when we work on a drug, we get very attached to that drug and it’s very difficult when the drug is not doing well, maybe to make the decisions and that’s where the Statisticians may be more fact based on the evidence base. I’m not saying you’re not attached to the drug as well because I’m sure they are but I think that’s where we can play a big role and really put the evidence together so that the right decisions are made at the right time. And the way I see it is that when you discontinue a drug, I see it as a success and why I see it as a success is because you’re going to be able to use these people and the money you have for another drug that is more promising, and you’re not wasting patients time as well. We have a drug that will not deliver. So I think it’s where I really want the Statisticians to contribute and help the company make the right decision.
Alexander: I completely agree. It’s all about accumulating the right evidence over time. Yeah, initially it’s for internal decision-making, later it is for regulatory decision-making and ultimately, it’s for decision-making with a physician and patients. Overall we Statisticians are much more successful, I think we can actually, also from an organizational point of view can play a much bigger role across the industry. I think we don’t need to be cornered in some kind of operational area, or we won’t be in the position where we have this effect like, as you said, well, we call the Statistician when we need to write a statistical plan. If we are collectively better in terms of leadership that will create a halo effect for everybody working in the organization and will speed up things for everybody, it will make things easier for everybody and I think it will be also easier, for example, to get some resources that we need, to get the training that we need, to have automatically a seat at the table when these things are discussed. And ultimately I think it will also make us more successful to transition out of statistics. If we have Statisticians that are collectively becoming better leaders, then it will also be much more attractive for other functions to hire Statisticians and make them VP of regulatory or you know the head of the R&D area or maybe one time the CEO. So why not? Where is it written that that needs to be someone from marketing or Sales or someone from Finance or a chemist? Why can’t it be a statistician? Yeah, literally, one of the Statisticians became the CIO and was reporting to the CEO. So yeah, if the Statistician can do that, why not?
The industry is so much more driven by data across all these different things. You know, if you think about Marketing sales, that’s a lot about data-driven things. If you think about medical affairs it’s a lot about data-driven things, if you think about all the finance and procurement stuffs that’s anyway, data in its purest form. Yeah, it’s data wherever you go, and the times where we went out with slogans and, you know, sold our drugs based on slogans are far gone. So I think there are ample opportunities for statisticians, but I think we need to ask functions to become much better in terms of leadership and we can raise the tide and raise sales and all boats are getting higher. So that involves a little bit of me on the soapbox. What do you think about that?
Claude: About Statisticians becoming CEOs?
Alexander: Potentially.
Claude: Yeah, I don’t know if most of them would like it first because I think maybe the mindset is a little bit different. But what I think is that right now companies are not benefiting from the Statisticians as much as they should and I think Statisticians are really underused and we’re all trying to be quicker, first, the patients are there waiting but I guess we also want to make money and be the first one to the market. And I see many companies trying to save some day, here and there, and can you log your database quicker and can the medical writer write, you know the CSR faster. But for me, that’s not what’s going to make the difference. The difference again is really when you build with the clinical development plan and when you design the trial, how can you be faster? How can you collect the evidence in a way that maybe you do fewer trials? Or you need a smaller sample size, or you have less space between trials and you can transition much faster. And that’s where I think Statisticians can do a lot for the companies.
Alexander: Yeah, completely agree. It doesn’t matter in the end if you develop the results within two or three days after the database log, that will not change things. But if you can, you know, shorten the recruitment time by 50% then, that’s a topic. If you can decrease the placebo rate by 50%, that’s a topic. If you can get rid of a complete study that will make a change. Yeah. Or if you can say, well, we move that study out to pass approval. These things will make a change. I completely agree.
It’s the same also later on, if you have the drug approved, yeah. Can you create evidence really fast without running your studies? Or can you set up observational research so that from this kind of research you can answer any analysis very fast? First, going through six different groups takes you six months to get to an answer.
Claude: Yeah, it’s really about utilizing the totality of evidence and now we have real-world data which is not perfect yet and we all know that, but it has some value. And if it’s used that way, I think that that can play a big role. And I really think the Statisticians also have to learn to work with this kind of data, because clinical trial data and real-world data, really compliment each other and that’s a nice package. That can be used to gain some time or maybe to avoid running some trials as well.
Alexander: I completely agree, I think there are so many different data sources that we can use. Yeah, it’s a clinical trial. It may be combining clinical trials with real-world evidence, real-world evidence alone, it is indirect comparisons, and sometimes, you know, things like just a patient survey help quite a lot. Yeah, and you can run this very cheap, very, very fast. And that may give you an answer. So from my point of view, as a Statistician, we should have all these different evidence sources in mind and not just a few studies that we set up ourselves.
Very good. So if we think about leadership, going back to the topic, what’s your number one tip to become a Statistical Leader?
Claude: Well, for me, it’s really about leaving your comfort zone and becoming visible. So I think Statisticians are still too invisible. You know, people kind of know, they exist, people kind of know or think they know what they do, but I think it’s really our job to explain what we do, to explain what we could do, and that will not do it yet. And how we could benefit, and it’s not arrogance or anything like that, but it’s just making sure people understand the potential that we have and trust us so that they let us use it.
Alexander: I completely agree, it has nothing to do with arrogance. If you explain, for example, to your Sales Marketing Organization, to your Pricing and Reimbursement Organization, to a Medical Affairs Organization, to your Toxicology Organization, how you can help them, I would turn it around, it’s a disservice if you don’t. Because then you leave them alone with their problems and they might think, oh, that’s cool, my problem. Ah, there’s some kind of companies that can help me with that and they go to some kind of random CRO where, you know, just picking up the phone and calling the Statistician would have helped them directly. So, having good internal marketing for you personally, but also for your organization, I think it’s a must-have for Statisticians to have. You can then show what you can help, how you can help, how you actually understand them, and where the pinpoints are.
Claude: Absolutely. Unfortunately, most statisticians are not very good at that. You know, at explaining what we could do at maybe branding ourselves a little bit. And showing the potential of all these techniques and all the data we have access to, yeah.
Alexander: Usually some Statisticians in the organizations really love doing that if they have more time for that, so that’s a good thing. There’s actually one thing that I think Statisticians are really good at, and that is training, training others in statistics and that is also I think a great marketing tool. Yeah, so for example there’s a new phase two study that has a readout. Don’t just let the Physicians talk about it. Yeah, explain as Statisticians what these data mean and explain why your phase two study looks different than the competition. Yeah, you can become even more important when you get to the phase three results because then you reach a bigger audience. Don’t just leave it to the others to talk about the data, talk about the data from your perspective, talk about their strengths and limitations. What does it actually mean?
I’ve worked with lots of Physicians that would be more than happy to invite the Statisticians as well to let you know, partner up and speak about these things. I think that’s a unique opportunity that we have.
Claude: I agree, I think that really medical and Statisticians teaming up, you know, that’s a very strong team for sure. And you make sure that they are understood the right way and that they have the right impact too. But also there are limitations on how people understand them because it’s not always perfect. And I think Integrity, which in the Pharma industry is the number one, is very important and the Statisticians can explain that too.
Alexander: I think that is also a big asset that we have. Whenever I talk, for example, to key opinion leaders. I had such a feeling they trusted me as a Statistician much more since I trusted other functions, that’s an asset that we should bring to the table. Also because we
can make complex data understood easily, which also helps with building trust. And so these things are really, really important in our business and they will only grow in importance. I’m sure.
Claude: Oh yeah. Absolutely. You know we have more and more data as you were saying before and so I think the job of Statisticians has a very bright future ahead of them for sure.
Alexander: Thanks so much, that was a very good final sentence. Thanks so much for coming on. We talked so much about leadership and about your leadership journey, about coaching versus mentoring, and what it actually means to be a Statistician. Why providing a safe space
is so important for improving the speed of Innovation for creative ideas. We talked a lot about the Statisticians, an organization full of strong leaders, and how that can turn the needle around. And it’s not about this, you know, one day here or there that you can carve out that really about the bigger things and that it is really important to keep stepping outside of your comfort zone.
Claude: Yes, absolutely. Well, thank you, thanks, for inviting me.
Alexander: I’m producing this podcast in association with PSI, a community dedicated to leading and promoting the use of Statistics in the healthcare industry for the benefit of patients. Join PSI today to further develop your statistical capabilities with access to the video-on-demand content library, free registration to all PSI webinars, and much more. So, the reduced rate is only £20 for non-high-income countries, and £95 pounds for high-income countries, head over to psiweb.org to learn more and become a PSI member today.
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