The Effective Statistician - in association with PSI

Are you a sponsor who is seeking joint scientific advice from a regulatory agency and from an HTA body? If yes, this episode is for you. This presentation replicates the discussions which may go on during scientific advice. The example was in Respiratory. This roleplay is played by David Wright, Oliver Keene, Stephen Ruberg, and myself. The aim is to show a couple of discussion points and an inter...

As statisticians, we work in cross-functional teams, but many people, especially junior people prefer to follow rather than to lead - and that's okay. Ask yourself: Do you always take the position of the follower or a leader? Do you need to train yourself to lead? Are you seen as an implementer? Do you have goals for your project?

A lot of statisticians, especially in pharmaceutical companies but also CROs, fear outsourcing because it might make their job redundant. Think about: What can you do about it? How can you add value to your organisation? What would it cost to outsource your organisation? If you would need to compete with other organisations, would you survive?

Storytelling allows businesses to better understand insight. Data visualization is a great tool to help share, or tell a story, but relies on the story being written first. Improved data communication comes from combining good visualization with a well-written narrative. There's a lot to learn to be a good data storyteller. Today, I’m talking with Kat about: - What do you understand by storytellin...

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...

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 spe...

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 ther...

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 present...

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 y...

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...

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 studie...

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...

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 Pharm...

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 a...

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 w...

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)....

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 statist...

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...

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 ep...

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.