Help Your Company Know What It Knows (Part 2)

Transcript

Help Your Company Know What It Knows Part 2

[00:00:00] Alexander: Welcome to another episode of the effective statistician. Today we will talk a problem that I have mentioned in some earlier episodes. [00:00:10] And that is about the problem that your company probably doesn’t know what it knows. And that really goes to the [00:00:20] problem that you create so many tables, you create so many figures, listings, whatsoever, all these kinds of different things.

[00:00:27] Alexander: And then say good. [00:00:30] You know, distributed and reports and publications, slide sets, all this kind of different things. And it is really, really difficult for [00:00:40] anybody to understand what is actually all set. Just for, you know, simple compound. Yeah. As soon as any compound has [00:00:50] multiple studies on it. It gets really, really bad.

[00:00:55] Alexander: Yeah. And so very often companies just rely on one [00:01:00] person that knows everybody, but knows everything. But what if that person leaves the company, or is sick, or whatsoever, needs to move on [00:01:10] to the next project, then you really have a challenge to understand what you actually know. And the bigger the product becomes, the more studies you have, [00:01:20] the longer the time period, the more worse it gets.

[00:01:25] Alexander: So, if you want to change it, I’m going [00:01:30] through a couple of different steps that you need to go through in order to make sure you change this pretty bad and [00:01:40] also, I think, pretty risky situation. So, the first step that you need to create is Urgency. [00:01:50] Urgency means you need to make sure that important stakeholders understand how much risk there [00:02:00] is, how much waste there is in terms of people time, but, but also money.

[00:02:07] Alexander: Yeah. And very often you can [00:02:10] translate kind of the times that people spend searching for things or recreating things, how much that is actually costing. [00:02:20] Or if you outsource these kinds of things, then of course, it’s even easier to put some kind of numbers next to it. And you can make some assumptions.

[00:02:28] Alexander: Yeah? Assume [00:02:30] like, how often these kind of things occur, how long it takes for everything like that, and you can have kind of, you know, conservative [00:02:40] assumption like of happiness. Only so often, and maybe another scenario where you think like, this is more realistic [00:02:50] scenario and can build some kind of model around it.

[00:02:54] Alexander: Okay, so often, so much time and that is kind of the risk. [00:03:00] Yeah, you can make some probability assumptions about it. Well, what is the risk that You [00:03:10] may not report something to the FDA, although you actually know, or that some lawyers who then actually go through every [00:03:20] page will find out about something that your company knows because it is in some kind of table, but [00:03:30] wasn’t communicating about it.

[00:03:33] Alexander: Think about all these different things. There’s another thing that you can think about. All the missed opportunities. Peace. [00:03:40] Yeah, what kind of processes would be possible if your company knew what it knows? [00:03:50] So translate that all into money, but also think about what kind of hassle it is for the different colleagues that you work with.

[00:03:59] Alexander: Yeah. So [00:04:00] many people will not be triggered by, Oh, it costs money for the company. Well, it’s not their money. that they are triggered if [00:04:10] it just makes their work very, very difficult. Yeah. So for example, medical writing, yeah. If it’s really, really difficult for them to kind of [00:04:20] find all the data, yeah. Or for someone in regulatory, if they find it really difficult to have a good overview of everything.

[00:04:29] Alexander: [00:04:30] Because they always need to call the project statistician. Yeah, and then the project statistician is anyway already super busy with things and doesn’t have time. [00:04:40] So think about these different things in the first step that is creating urgency. So the second step that actually more [00:04:50] or less goes in parallel with that is find allies.

[00:04:54] Alexander: Find people that see it the same way like you, that there needs to [00:05:00] be some change. And these are the people, when you talk to others, who say, yeah, it’s a hassle. It’s a problem. We waste so much time, money, [00:05:10] whatsoever. It would be so nice if. So if you talk to people and you step over these people, these are likely your allies.[00:05:20] 

[00:05:20] Alexander: And it’s great if you have allies from different functions as well as allies in, let’s say, on the [00:05:30] worker bee level, as well as to a more executive and senior management. Because People at these different [00:05:40] levels have different influence in the organization. And don’t underestimate the frontline worker influence.

[00:05:49] Alexander: [00:05:50] They have a lot of street credibility with their peers. If someone really experienced senior in that area talks about [00:06:00] something, Lots of people will actually listen more than if some kind of VP that is supposed to be rather removed from the actual [00:06:10] work talks about things. So talk to these people, find allies, find a team that wants to work together to [00:06:20] change that.

[00:06:21] Alexander: current situation. As you do that, you will probably also discover some roadblocks. Yeah. [00:06:30] So are there any specific concerns like what about regulatory? What will the FDA say? What about We don’t have the [00:06:40] processes for that. We don’t have that. Our vendors don’t support that. That will require further standards whatsoever.

[00:06:48] Alexander: All these kind of things. [00:06:50] You can note them down all because all of these will be something that you will need to address sooner or later. You can also [00:07:00] understand Who are likely the naysayers in your organizations. The people that are always against the change. [00:07:10] And maybe for personal reasons. Maybe for their resistance to change anyway.

[00:07:16] Alexander: Or maybe it is just that they don’t really understand. [00:07:20] How that could be possible, you know don’t pull these people into your team, into your change team, because they will, you know, stop [00:07:30] everything. However, think about sooner or later, you will need to kind of bring these people in. And it’s good to understand [00:07:40] their concerns, to understand, not to kind of accept that because most of these concerns will be excuses.

[00:07:48] Alexander: Yeah. Ah, we [00:07:50] have never done this that way. That’s not possible. Regulatory will not do that. The FDA doesn’t agree with that. That’s not part of the CDISC standard whatsoever. Yeah. So, [00:08:00] people will come up with all kind of different things. These are really excuses. The next step is, [00:08:10] so after you have identified your allies and you have created a sense of urgency, you can craft a compelling vision.[00:08:20] 

[00:08:20] Alexander: And this compelling vision puts in all the different aspects into that. How life will be [00:08:30] easier, faster, cheaper, higher quality less waste, all these kinds of different things in the future. And [00:08:40] within this vision, and this vision is not just a, you know, a buzzword sentence, it is a story, yeah, it can [00:08:50] span a couple of slides, couple of pages, yeah, thinking about all these different aspects, how things will be different, how things will be different in [00:09:00] terms of CSR writing, how things will be different in terms of finding data, here, some summary statistics.[00:09:10] 

[00:09:10] Alexander: How things will be different of doing post hoc analysis. How things will be different in terms of submitting manuscripts, [00:09:20] writing posters, all these kind of different things. So speak about that, yeah? And craft a vision that speaks to all the [00:09:30] different functions that will benefit from this future. And that for sure also includes functions that maybe are not so Well aware [00:09:40] about maybe, you know, marketing, medical affairs, maybe you never work with these, but these will definitely benefit a lot from that.[00:09:50] 

[00:09:50] Alexander: The next step is then to craft a business case. So if you have never done that, a business case really outlines [00:10:00] what needs to be done, what will be the cost, what will be the benefits, also in terms of money, usually money, [00:10:10] quality, things like that. Yeah, the more tangible benefits, the money side, and some more or less tangible things like quality, [00:10:20] people satisfaction at work, things like that.

[00:10:27] Alexander: It is important to [00:10:30] not directly go to, Oh, we’ll do that and completely change everything. Yeah. So these five year plans. [00:10:40] Rarely get accepted by management, especially because nobody believes that, you know, this five year plan will actually work out. [00:10:50] And the second thing is it usually costs a fortune. So break it down into more simple steps.

[00:10:58] Alexander: Yeah. Maybe [00:11:00] the first step is that you just do some kind of. feasibility study. Or maybe the first step [00:11:10] is that you bring in someone that is really experienced in terms of that, who has expertise in this area, and [00:11:20] you put a plan together. So maybe you just ask for a little bit of money from a consulting period, a consulting site.

[00:11:29] Alexander: [00:11:30] So that could be the first step. You can, of course, in this business case, already outline what would be step two and step three and step four, [00:11:40] but make it easy for senior executives to say yes. Yeah, if they can see, okay, that is a longer term plan, but actually [00:11:50] at first I need to approve XK 1000 euros or dollars, that is much easier than if you come and say, [00:12:00] Oh, we want to invest so many FTEs over the next three years.

[00:12:03] Alexander: And by the way, it will cost 2 million. Then it gets much harder. Of [00:12:10] course, the bigger the gap between the cost and the return on investment, the easier it is to convince people. And [00:12:20] also that takes care of the uncertainty. Yeah, the costs are usually much more certain than the, than the return. And [00:12:30] so If you can show, well, there’s a 10x return on the investment, then it is very likely that you will at least get any return on [00:12:40] investment and that will be a good investment.

[00:12:42] Alexander: If you make the calculation and well, over the next three years, you’ll only have a return of 1. [00:12:50] 05. The investment, the likelihood that actually the investment is bigger [00:13:00] than the return is very, very big just for the uncertainty reasons. So it needs to be a really, really compelling case. However, I think [00:13:10] this is a really, really compelling case.

[00:13:14] Alexander: So think about money, timelines, resources, and these minimal steps [00:13:20] that you need to do. You can always take, you know, further enhancements into the future. The next step that you then need to have is [00:13:30] get experienced change management support. Changing these things is hard, you know, and because of [00:13:40] that, actually, the vast majority of these change projects actually fail.

[00:13:46] Alexander: And because people here think, Oh, I can do [00:13:50] that by myself. We just need to change the processes. No. The problem is that you need to take the people with you. [00:14:00] And the bigger the organization, the harder it is. But of course, the bigger the organization, also the bigger the benefit is, you know. But you always [00:14:10] need to think about the problem is not in the processes.

[00:14:15] Alexander: The problem is in the [00:14:20] brains of the people. in the attitudes of the people. And to convince them to actually do something new, to support something new, that is the [00:14:30] hardest part. And this requires hard work and it becomes much harder if you’re not aware what you should actually do. [00:14:40] So a change management consultant or change agent person and If you don’t know any who has [00:14:50] worked with statisticians, I can refer you to, to one who is really, really good.

[00:14:57] Alexander: They will understand exactly the problem. [00:15:00] They understand the issues and they know how to respond to these different issues. [00:15:10] Having someone like that will greatly speed up everything. Yeah, and also it takes time away from [00:15:20] your time because I’m pretty sure you have other things to do. Yeah, and so this change agent consultant can [00:15:30] actually help you a lot.

[00:15:31] Alexander: So that is the last step. And I want to stop here because. From there on, everything will rely [00:15:40] on this change management agent that can help you drive it from here. So, the five steps. The first is create a sense of [00:15:50] urgency. Second step, find allies. Third step, create a compelling vision. Fourth step, do a business plan.

[00:15:59] Alexander: And the last [00:16:00] step, then bring in someone that can help you with all the other steps. And that person will actually explain to you what are all the other steps. [00:16:10] And then, in the end, you will have a new organization that knows what it knows. And I think this is [00:16:20] really, really cool. So stay tuned for more episodes about change topics and lots of, lots of further innovative ideas.[00:16:30] 

[00:16:30] Alexander: If you love the effective statistician, then please tell others about it as well. There are lots of, lots of great things coming up. And as you know, [00:16:40] I’m now publishing my book. At least twice a week, maybe three times a week, sometime in the future. That is at [00:16:50] least the plan for this year. And there’s a lot of additional cool stuff in the works.

[00:16:56] Alexander: So, watch out for that and [00:17:00] please tell others about the effective statistician.[00:17:10] [00:17:20] 

[00:17:20] Alexander: You are listening to the Effective Statistician Podcast, the weekly podcast Pieske designed to help you reach your potential, lead [00:17:30] great science, and don’t have a breakdown on your work life balance. So, today we will talk about [00:17:40] helping your company to know what it knows. And now, some [00:17:50] music.

[00:17:51] Alexander: Do you focus on SAS only? Well, there is a lot happening on the R space. And if you [00:18:00] want to become part of this fast growing community, then maybe you don’t know where to start. There are a lot of people that [00:18:10] do amazing things with R. And if you want to do the same things, well, why not invest in your R skills?[00:18:20] 

[00:18:20] Alexander: If you’re already pretty good on the south side, then I have the right course for you. Together with Thomas Nietmann, who is an [00:18:30] amazing trainer in terms of software programming, in terms of statistical programming, you can learn R the [00:18:40] easy way. In the upcoming course, SAS to R with Thomas, you will learn through six live [00:18:50] sessions.

[00:18:50] Alexander: Well, actually, we already did that last year, and all these six sessions are also already recorded, so you can just follow these. [00:19:00] But you can also attend the live training. And then, of course, you will directly have the opportunity to ask questions to Thomas and to do [00:19:10] all the things on the R programming side while the course is running.

[00:19:15] Alexander: So that will be a great treat. We had lots of, lots of [00:19:20] good feedback from this course already. And last time we ran it in the European morning, so that was good for Europe and for [00:19:30] Asia. But not so much for the US. And this time we actually run it in the European afternoon. So that will be good times for the [00:19:40] US, even to the West Coast.

[00:19:43] Alexander: Maybe a little bit early, but not too early for the West Coast even. So, Head over [00:19:50] to the Effective Statistician, look for the courses of the academy, and there you will find the link to the SAS2R course. So that [00:20:00] starts again in April, so hurry up and get your seat. That will be awesome. I’m producing this podcast [00:20:10] in association with PSI, a community dedicated to leading and promoting the use of statistics within the healthcare industry for the benefit of [00:20:20] patients.

[00:20:20] Alexander: Join PSI today to further enhance your statistical capabilities with access to the video on demand content library. Free [00:20:30] registration to all the PSI webinars and much, much more. Just head over to psiweb. org and learn more about PSI and become a member [00:20:40] today.

[00:20:43] Alexander: This show was created in association with PSI. Thanks to Rain and her team at VVS who [00:20:50] helped with the show in the background, and thank you for listening. Reach your potential, lead great science, and serve patients. Just be an [00:21:00] effective statistician.