The Effective Statistician - in association with PSI

There is an endless list of things that can go wrong in sponsor-CRO relations. I’m pretty sure you have been in painful discussions about this. Have you felt a lot of frustrations on both ends? If yes, this episode is for you. We’re sharing interesting insights here as Benjamin works for a CRO and I work for the sponsor side. We will be giving you a lot of insights on what to do and what not to do, and how to make the collaboration between a sponsor and a CRO successful.

The 2019 PSI Conference took place at the Queen Elizabeth II Centre (QEII), London, with the theme of “Data Driven Decision Making in Medical Research”. The sessions included early phase innovative trial design, industry best practice, statistical issues in safety drug labelling, model-based dose-finding designs, an update from Transcelerate and much more. In this series of interviews with the speakers at the conference, we talked about different topics: - Visualization software - Benefit risks approach - Global statistical test for multiple endpoint analysis - Estimands - AE analysis using a volcano plot

Do you agree that everybody makes mistakes? Have you had to deal with a mistake yourself, that you were really concerned about? Were you afraid about speaking with your supervisor or your team with it? We are all imperfect humans making mistakes. The questions are: how do we deal with them, what we can do about them, and what to do to minimize them. Processes are made to minimize mistakes and there different processes were set up to deal with mistakes and help you when mistakes occur.

Have you been sitting in boring presentations that made you start reading your emails? Have you been listening to someone, wondering if this is for me? Have you been getting away from a presentation and thinking 2 hours later: “what was this about?” You’re surely don’t want your audience to feel this way, when you’re presenting yourself. You can’t be an effective statisticians without good presentation skills from my perspective. You will always need to present results, defend designs, or explain data. Todays episode will give you insights into 7 mistakes of presentations. And honestly, I see at least one of them in nearly every presentation and I struggle with them as well – just listen to this episode and you’ll have a live example 😊.

The last PSI conference has just ended, but the timeline for a new abstract submission for the next one in Barcelone in 2020 will come up in about November 2019. Thus, it’s important to now start thinking about it. Presenting at the PSI conference is an awesome experience. For me, PSI is by far the best conference for statisticians in the health sector as it is 100% applicable and actionable. If you’re abstract gets accepted for oral presentation or as a poster, you have a great argument for convincing your supervisor to approve the travel to Barcelona. If you think, this is to much of a stretch, because you’re not located in Europe, just think about a different conference. Join the challenge to submit an abstract and work together with others to overcome and roadblocks!

I recently changed my job and moving from one company to another comes with lots of uncertainty. Will I pick the right one? How can I make sure, that I actually get the job, that I want? Will hiring companies find me and offer me jobs? For any statistician a job change represent a major shift and occurs rather infrequent – hopefully. For a recruiter – this is day-to-day business. Look out for lots of great learnings and insights!

Have you ever considered to work with a placement student? Do you consider to spend some time as a placement student yourself? In this interview with Katie Thorn and Claire Brittain, we’re exploring factors, which help to make it a win for both sides. Both have worked very well together and share their stories.

I recently talked to a statistician, that initiated a small company internal group of statisticians to drive forward methodological innovation projects. While this surely will help the individuals to learn more about statistical methods, it was less clear, why and on which topics the group should focus their activities on. While most of our day-to-day activities consists of running clinical studies, submissions and directly related work, we also engage in such innovation work streams or process improvement working groups and other such activities. Today, we’re giving you advice on how to best pick the right projects to work on as you usually have some influence on this.

As statisticians in the medical field, we’re used to study subgroups of patients with respect to all kinds of biological variables: from demographics to genomics. This provides us with a good understanding of how the benefit-risk profile for a given patient looks like. However, the patient might have a completely different view on the importance of the different benefits and risks. And importantly, these preferences might be less driven by biologic factors and more by personal experiences and situations as well as psychological traits. How can we assess patient preferences in this regard? Marco Boeri and I worked on such questions in the past and some work has been presented at last years PSI conference. In todays episode, we give you some insights into what’s possible and how you can approach this problem.

Estimands continue to be a hot topic, but many statisticians struggle to put it into practice. As statistician, we wonder about the correct interpretation and how to analyse different estimands. In todays episode, we speak with Michael O’Kelly, an expert on this topic with lots of presentations around estimand (see e.g. the PSI events). He also won the award for Statistical Excellence in the Pharmaceutical Industry, jointly run by the RSS and Statisticians in the Pharmaceutical Industry (PSI).

One of the most common questions I got asked during my nearly 2 decades of being a statistician sounds similar to this: “Which patients have the best response to treatment?” I’m sure, we all face this situation sooner or later and not surprisingly lots of research has happened in the last years on this area. In todays episode, we will help you to understand one of the best approaches I have come across to solve this problem in a rigorous yet sophisticated way: the SIDES approach. Both Andy Nicholls and I have applied this approach in the past and we’ll use an example, which he presented during a PSI webinar. Listen to this episode to learn step by step how to apply the SIDES method.

Prespecified=good and post-hoc=bad. This is how we as statistician see it usually and I did too. However, over the past years I realized more and more, that it’s not that easy. How many details do you need to have to call an analysis pre-specified? Should we label a request to analyse a certain subgroup by regulators as well as a fishing expedition to find a significant subgroup both in the same way: post-hoc? Lovisa and I together with some others are presenting at the next PSI conference about this topic and today, we dive already into this topic and identify different dimension to be considered to understand better the different shades pre-specified analyses. Listen to this episode to avoid oversimplification and confusion in discussions in the future.

Analysing binary or continuous data usually doesn’t cause any headaches for statisticians. But when we step into ordinal data, most of us ignore their specific nature and either dichotomize them or analyse them as if they are continuous. Recently, these problems have becoming much more prevalent due to the nature of composite endpoints (watch out for an interesting episode on this in a few weeks). Now Benjamin and I have worked on better tools to analyse such data already at university. We’ll dig back into what we learned then and what is still relevant today.

Risk-based monitoring plays an increasingly important role for clinical trials. Of course, the assessment of the risk is based on statistics. This presents now only interesting career options for statisticians, but also has an impact on the role of statisticians in study teams. In this episode, we’ll give you an introduction to risk-based monitoring (RBM) as well as speak about the role of statisticians in this area. Further we provide you as a study statistician insights into what you need to know about RBM. Finally, we also give some recommendations in terms of further resources to learn from.

1. Start with a relevant example 2. Collect questions upfront and track progress of answering them during the training 3. Create regular meetings to engage people 4. Interrupt your presentations with asking questions 5. Use contrasts to show the impact 6. Have a physician first introduce the example study 7. Don’t shy away from speaking to very basic things like p-values 8. Prefer white board over slides 9. Use technology for your advantage in virtual settings 10. Make pre-read easy 11. Collect feedback

Ultimately, we work to improve patients lives but traditionally the voice of the patient was not important. However, over the last decades many stakeholders shift to include the patient more in the decision-making process and patients voice their needs and preferences more. Still capturing and evaluating patient preferences does not belong to the core capabilities of most biostatisticians. This episode will help you to understand patient preferences.

Are you early in your career and you could still go for a PhD in statistics? Do you wonder, if this pays out short and long-term? Is it worth the money? What are the long-term benefits or are there actually short term benefits as well?

Do you want to change your job? Are you just looking for you first job? Do you consider to work for your own company or as a free-lancer? Then this episode will help you!

Benefit-risk assessments are made by various stakeholders including sponsors, regulators, payers, physicians, and patients throughout the life-cycle of a treatment. The understanding of data plays a vital role in weighting positive and negative effects of medications. In this episode, we give you an introduction to what benefit-risk (BR) assessment is in order for you to understand your role.

In this episode, we talk about - how to network - how to prepare for the conference - how to follow up after the conference As well as some specific topics around the PSI conference itself.

This episode follows the outline of a webinar, that I presented in 2018 during a PSI webinar. I’m introducing cluster analysis and why you as a statistician need to know about it.

There’s a long tradition of statisticians working on clinical studies as well as other related data, e.g. pre-clinical data and observational data. In the advent of big data and data sciences, there’s a considerable pull from the business side of pharma to employ statistical approaches as well. What does this mean for medical statisticians?

Do you want to learn where the health sector might be heading in terms of data science? Do you understand the opportunities and barriers in terms of the application of data science? Are you prepared to learn the individual skills needed for these changes? Then this interview with Ursula from Cytel provides you with the relevant answers.

It's surely not the norm, that a statistician from the pharma sector ends up working for BBC. But Robert Cuffe has taken this step and needs to explain statistics to non-statisticians on a daily basis. In this episode, he shares the different methods he’s using. We also dive into common pitfalls, that we as statisticians trap into. Finally, we also learn, how we can improve our publications to make sure, that the science is reported correctly in the broader news.

Do you know that TransCelerate does for statisticians? Do you write study protocols, analysis plans and programming specifications as individual documents noting, that there’s lots of redundancy? Do you wonder, if there’s a more efficient was in-line with what regulators want? Pepa Polavieja will provide you with answers to all these questions in this episode.

Do you think, R can’t be used for regulatory submissions? Are you forced to use SAS but would like to use R instead? Would you like to understand how you can make R submission proof?

In this last part of the leadership series with Gary Sullivan, we talk about the next steps, you can take to work on your leadership skills.

In the third part of the leadership series with Gary Sullivan, we talk about: - What skills does it takes to influence as a statistician? - When it’s about driving change - what are the rational, operational, and emotional challenges? - How do I get a "seat at the table" and have more influence?

n this second part of the interview with Gary, we speak about the building blocks of leadership without authority from a statistician’s perspective. We cover questions like: - Is influence the same as power? - What is the role of trust, what are the different elements of trust and how can we improve trust being technical experts? - How can we build relationships at work, that help us to influence change? - Is influence through relationships only relevant “sideways” or also “upwards” and “downwards”? - How do we know, with whom we need to invest in building relationships? - Is there a way of assessing how good our relationships are?

This is an announcement episode of an upcoming free webinar. Learn more about this webinar and register for it at theeffectivestatistician.com/webinar.

With some nice drinks in our hands, we welcome the new year and commit to new year resolutions. We set our personal goals and pretty soon, we’ll have discussions at work about business related goals. This episode will help you to not only be ready for the discussions with your supervisor, but also give you tools to reach the goals with better probability than the usual vague new years resolutions.

Happy Christmas! This episode is the last one in 2018 and we will distil the best of the last 40 episodes for you in this Christmas edition of the podcast. It has been anamazing journey and we will talk about the challenges and the learnings as well as the achievements of the podcast itself. Thus, you’ll get a behind the scenes look into the podcasting work.

KOLs play a major role in the health sector and professionally working together with them will boost your career! This episode provides you with lots of insights and tips. In this episode, we talk • about how the interactions between pharma companies and KOLs look like • which rules are important and how you as a statistician should comply with these • about practical tips of building relationships with KOLs • about opportunities to work with KOLs • and about mindset topics in engaging withKOLs

If you ask someone within the pharma world of statisticians on what is the hottest topic, you most likely will just get: Estimands! Many scientific events, conference sessions, publications and presentations are organized around this topic. Thus, I'm super happy, that we have Mouna and Chrissie on the podcast as they have presented about this topic at various occasions. In this episode, you will learn about - the importance of the concept itself and it’s implications - the terminology of the estimand framework - and how it relates to missing data terminology

Have you ever been proposing or defending a project in a larger meeting - maybe even with senior management - and it didn't go as smoothly as you would like? Or do you prepare yourself for such a meeting and you feel unsure about what to expect? Then this episode will help you!

Same procedure every year - the year end review as part of the performance management appears on your calendar. Are you worried about filling in forms? Do you feel like this is not adding value? In this episode, we give you practical tips how to master the review like a pro.

We're launching a new leadership course next year and in this episode, we go into some key questions about statisticians and leadership.

Today, regulatory approval doesn't ensure anymore, that patients benefit from new therapies. As statisticians, we also need to ensure access and reimbursement for new treatments in the different markets around the world. The process to gain this access and reimbursement in Germany comes with very specific challenges. Yet, due to the large impact of Germany on other countries via the complex reference pricing system and the size of the population of Germany, we must understand these topics. Andreas Schwenke gathered experiences across therapeutic areas with many companies since the start of the new process in Germany. This makes him the most experienced and best connected statistician in the world for this topic.

We're all making decisions to optimize our studies. Optimizing project plans across different studies presents further challenges. But how to increase the overall portfolio of a company given its limitations leads yet another set of challenges. Knowing how decisions are taken at this top level helps to understand the bigger picture and why this sometimes implies sub-optimal decisions on a study or compound level. Another big learning from these complex interactions are the influencing skills needed to work with senior and diverse teams. Only a few statisticians in the industry work in these areas and Andreas Sashegyi is of these.

You have probably heard about Simon Sinek and his golden circle. If not, have a look at his great TED talk. In this episode we explain via a nice story with BA, what the impact of starting with why can be. We also cover how you can more effectively work together with CROs and Programmers as well as new team members.

Becoming a supervisor changes things dramatically at work for you. It did for me and Simon helped me by openly providing deep insights into his years of a supervisor - especially his failures and dramtic moments.

Everybody knows such situations: tight timelines, high expectations and many things to do! But how can we work effectively in such situations. Many different productivity experts have written about this topic. In this episode, I’m speaking about how to implement these approaches and also my personal learnings and challenges during a time, where I needed them. I’m applying and discussing the following topics: Prioritization Delegation Managing expectations and communication channels Music as a productivity booster Make productive breaks Setting up a effective systems Methods against procrastinate Managing disturbances Setting up your body for productivity Multi-tasking The pomodoro method Morning routine Silence Affirmation Visualization Exercise “Reading” “Scribing” Habits to get into the deep work mode Deep Work by Cal Newport Working from home Some resources for productivity: Beyond the to-do list podcast This is your life podcast by Michael Hyatt In German: Einfach produktiv podcast with Ivan Blatter

Leadership skills for statisticians represents a common theme across many episodes of this podcast. As leadership consists of many different aspects, it is important to learn from other statisticians, that exhibit these skills. In this episode, we talk with Gemma and Margaret, who have run successful leadership courses within PSI. We cover the following topics: What are the core leadership skills that statistician need to be fluent in? What are common mindset issues, that block statisticians from being more influential? How can statisticians overcome these blocks? Why it’s beneficial for statisticians to have a tailored course for them? What courses are available from PSI?

Are you still counting tables? Do you worry about having to many of them? Do you wonder how to get an overview across all the results? In this episode, we will talk about this thoughts and we will explore, how tables fit into the bigger picture. We will also discuss alternative ways to deal with results, which will: - save you time - decrease the costs - speed up the process - and increase the quality. If you think, this sounds like magic, listen to this podcast episode.

Do you think, you have nothing to add to a statistical conference? Are you afraid of sharing your achievements? Do you wonder, why you should put in the effort on top of your day-to-day job? All these thoughts and questions will be addressed in this episode with Paul Terrill, the chair of the scientific committee of PSI. Beyond the questions above, we will also talk about the logistics and practical tips on how to submit your abstract and to become a speaker at next years conference.

We cover these topics: Why should you care What to do What to avoid

Understand multiplicity challenges in practical situations Learn how to actually implement it Learn where to get further information

In part 2 of this interview with Walt Offen, we cover: Having courage to speak up in all settings Listen carefully to others; ignore rank within the company Instituting any new rule or policy must affect the leader equally Grab opportunities when they come your way, even if you do not feel ready. See the issue from other’s perspectives Understand, appreciate, and celebrate diversity of thought, personality, skills, and beliefs Always strive to get better and help those around you Do not take “we’ve always done it that way” as an acceptable answer Be a solid role model Develop self-confidence; be able to laugh at yourself

In this episode, I have the privilege to interview Walt Offen. A statistician that is about to end an amazing career over a couple of decades of working in the pharmaceutical industry. Walt organized together, what he believes to be the 20 key attributes of highly successful leaders. They are organized in no particular order but enriched with great stories. Of course, there is a difference between leadership and managing. Leadership is the ability to inspire others when there is no supervisory control. For a highly effective organization, everyone can and should be a leader. In part one, we cover the first 10: Having a can-do attitude Being able to apologize Inspiring others to join the cause (without authority) Share credit Show humility Be trustworthy and develop trust in others Engaging everyone on the team, making them feel valued and important Remain calm, be kind to everyone Provide opportunities for others to shine Putting the organization, colleagues, the company, ahead of personal goals

In this very short episode, I'm stepping back from the day-to-day business and reflect about why we go to work every day. I have a very personal story about it, that helped me to see things very clearly and I'm sharing this in this episode. Further, many of you will listen this during vacation time and thus, I'm also touching on the importance of taking a break. There is no episode next week as we take a summer break as well.