Help Your Company Know What It Knows (Part 2)

In this episode, I guide you through our continued journey into the challenges around handling summary statistics. Building on our previous discussions, today we dive into the transformative solutions that extend beyond just the CDISC standards.

In Part 1, we navigated through the challenges of traditional data storage via CDISC, introduced results dataset storage, and discussed metadata’s comprehensive inclusion. We anticipated future needs, enhanced data visualization accessibility, ensured interface usability across teams, and established a feedback loop for ongoing improvement.

Today, the second part, shifts focus to your individual contribution and how we can drive change within the corporate landscape. We explore the power of understanding and leveraging your unique strengths and passions, the importance of individuality in fostering innovation, and how proactive change can significantly impact both our personal and organizational growth towards an organisation in which it is easy to find and re-use summary statistics 

Join me as we dissect these topics, offering insights into maximizing the value of summary statistics in our pharma world.

Now, I highlight some key points to keep in mind:

  • Build urgency for the change towards the future and build trust with allies
  • Let your company understand the value the change brings at personal and corporate levels. 
  • Take the initiative to make the change, gather a team, create a vision and get help from change management professionals.

Remember, understanding and communicating your true worth is essential for both personal and professional growth. By defining yourself beyond your company’s expectations, embracing your uniqueness, and taking the initiative to drive change, you can create immense value for yourself and your organization.

Share this episode with your friends and colleagues who can benefit from this!

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.

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