The Effective Statistician - in association with PSI

"A core outcome set (COS) is an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or health care".

The Introduction to Industry Training (ITIT) gives the delegates a taste of life across the pharmaceutical industry from early drug discovery to marketing, from CRO to Big Pharma and across the UK and continental Europe. The course aims to show the delegates the breadth and depth of work that goes on the industry and give them ideas of where they can get involved. PSI organized this course into 6 two-day sessions, each covering a stage of drug development and each hosted at a different company. The host company will give their unique perspective from experts in the field.

This is a very special episode. More than 2 years have passed since Benjamin and I started this podcast.

Do you know why is it so important to create a simple yet informative data visualization? How your design choices impact the visuals? How small details - like text alignment - influence the overall visualization? How gestalt principles guide you?

Are you stepping up as a statistician? Are you passionate enough in providing the value and helping society and the organization, and the people we serve?

The Corona Virus being discussed across the world, with all the visualizations there, it is really timely that I am speaking with Alberto Cairo. He is a visualization guru and has written the book "How Charts Lie". This book helps you as a statistician to understand various problems about charts, but more importantly, it helps you to educate your business partners that are not statisticians.

We all know how to specify a table and our processes support this. However, designing an awesome data visualization does not work this way. Our approach to table specification does not work?

As statisticians, we are one of the most capable professionals to understand and to relay the right information to the general public about the most talked-about situation - the Corona Virus. In today's episode, I want to express what's on my mind and on my heart about this topic. You can agree or disagree with this and let me know what you think about it. I also discussed my learnings, my reflection about this, and what is the meaning of this situation for us, statisticians.

Are you curious about how working from home works? How can you know if this is for you? What are the advantages and disadvantages when working from home? What is a good set-up when having a home office? The COVID-19 outbreak forces many of us to work from home. But even before this, working from home became a growing trend, most especially at the moment. This interview will help you understand if this is something for you or not, and how you can make it happen, have fun with it, and get a better balance of your working time and other things.

Why is visualization so important? How do you determine the goal of visualization? What is the big difference between explanatory visualization and exploratory visualization?

Who is Florence Nightingale and what is impressive about her? Why would it be interesting to talk about her at the upcoming PSI conference? She’s famous for her visualization – what could statisticians today learn from her about visualization? Listen now to learn more!

After a career that brought you as a statistician to various parts of the pharma world, what is the new job, that you just took on about? What are the unique skills of statisticians - beyond just knowing about stats - compared to many other functions in the pharma world? Which problems do statisticians need to take care of beyond the current regular work? How can we make time to tackle these problems? What skills do statisticians need to improve on to successfully tackle these problems?

Do you effectively communicate complex data? How can visualization help you when you are . . . analyzing data? . . . reporting data? What initiatives and groups work on this topic and will help you?

Real world evidence (RWE) Big data Real world data (RWD) Pragmatic studies There are lots of buzzwords floating around and especially with the FDA having a bigger focus on RWE. Many teams in the different pharma organizations concentrate on this type of evidence.

Do you know what your external profile is? Do you have an idea of how to improve it? In today's episode, Liz Cole and I will dive deep into a topic called content marketing. It’s kind of meta, since this podcast itself originates on these ideas. Does this sound frightening or disturbing? It shouldn’t.

With so many recent advances in AI, it is important for statisticians to both keep up to date with the most recent methods and getting involved in guiding their application to the most pressing statistical challenges. In today's episode, Karim and I cover cutting edge examples of how data science and statistical sciences are intersecting. Learn from this episode why different approaches matter when looking at clinical development data.

Do you feel you're working like a firefighter? Do you have the perception, you're solving the same problems over and over? Do you worry about ever-changing requests from your business partners? Then you are not alone - not even alone in the pharma world. In today's episode, we will talk about the data ops manifesto which addresses such problems. There are actually a couple of such manifestos out there such as the agile manifesto or the dev ops manifesto. These sound similar to Demings 14 principles outlined in his “out of the crisis” publication.

6 effective leadership behaviours for statisticians One of my favourite leadership podcast run by Olaf Kapinski - unfortunately in German - had a great episode recently (see here for the link to the Leben-Führen podcast: https://leben-fuehren.de/5-wirksame-verhalten-fuer-fuehrungskraefte/?pk_campaign=podcast&pk_kwd=5-wirksame-verhalten-fuer-fuehrungskraefte) Today, we’re reflecting on the 5 behaviours Olaf mentioned and add a great 6th one, which is very relevant as well.

Can you really do a bigger role? Did you have a moment in your career, where you were thinking that you as a statistician is put in a box or labelled in such a way that limits your influence?

Only specialized statisticians discussed indirect comparisons in the past but over the years the topic developed into something, every statistician should know about. In this episode, Benjamin and I talk about the important reasons for using indirect comparison (IC).

During this episode, we will review some of the highlights from this year. It’ll help you to remember a couple of lessons learned or inspire you to listen to some episodes (again).

So, hopefully you’ve listened to all of our other podcasts and you are still interested in applying for a job as a medical statistician… This episode will give you all the information you need to find out how to apply, CV tips and what to expect at the interview, and what to do and what not to do!

I once reviewed tables for a randomized study and noticed several comments about testing the baseline characteristics. The commenters were arguing which test would be best to test for the differences between the 2 randomized groups at baseline. This made my first angry about the wasted time and then curious about the reasons, statisticians still do this. In today's episode, Benjamin and I discuss some backgrounds for baseline testing in randomized studies. Listen to this episode, share it with others who might learn from it, and be an effective statistician!

What's interesting about the early phase? What are the typical decisions for phase II? Speaking about a new indication, how do you see decisions are being made across the industry? How should we think about phase II studies in this setting? What statistical approaches do we have to formulate this thinking?

So, you want to be a Statistician in the pharmaceutical industry, a key player in drug research and development, but you are wondering what employers look for in the perfect candidate? PSI CALC are here to share their top tips on being the ideal candidate, what to expect when you apply and to share their ideas of what the industry is currently looking for in a graduate statistician.

Do you know how to make a good to-do list? Do you know how to set priorities versus time it takes? Do you have a problem with over-committing? One of the most effective skills you can have in life is effective time management. According to Michael Hyatt: "What gets scheduled gets done. " If you're not managing your time well, there's no way you're going to reach your goals at work and the life outside of it. Marc Zao-Sanders - time boxing as the number 1 ranked tool for productivity among 100 tips

Do you want to have fun at work? Do you want to experience satisfaction? Do you want to get things done at work? Getting into flow is about these things. Today, we will speak about a research on how to get into the flow and reach your peak performance.

So, you’re considering pursuing a career in Statistics but you’re not quite sure. You may be at Uni studying a BSc in Mathematics or a related field, or you may be considering a change in career. How do you get from where you are now to being a Statistician in the medical industry? What are your next steps? This episode will cover what to start thinking about now, where you can get further advice on MSc courses and funding and where you can search for jobs.

Do you often find your workday spiraling out of control? Do you want to be more productive than you yesterday? Do you want to know how to improve your skill set and work performance? Do you start each day with a plan, but soon become distracted and procrastinating? You are not alone. Sometimes, it’s easier to wait for someone else to tell you what things you should work on rather than to assess yourself. Focusing on continually improving your skill set will boost your confidence and help you become the best version of yourself. In today's episode, Benjamin and I discuss what you need to know to increase productivity. Listen now to be an effective Statistician!

How do you know if you are an introvert? Is it possible to lead successfully even as an introvert? Do you know how to be successful being an introvert? People who are introverted tend to be inward turning, or focused more on internal thoughts, feelings and moods rather than seeking out external stimulation. They tend to be more quiet, reserved, and introspective. Unlike extroverts who gain energy from social interaction, introverts have to expend energy in social situations.

Statistics isn’t traditionally known to be a trendy subject, but here we are saving lives around the world by developing new and mighty medicines. You’ve probably heard by now that data is basically gold, and fortunately we statisticians work with data. Now that’s a lot of power we hold, so let’s put it to good use! - What kind of companies are out there? - Statistics is needed to produce revolutionary new medicines - yes, really! - Will I be at a desk all day, on my own, in a windowless room? - What’s a typical day? Excite me.. - Learn about different diseases - Not just a stats nerd - the other skills that are VERY important

Do you know why network meta-analyses (NMA) important? Do you wonder what steps are included in NMAs? Network meta-analysis is a very important field, especially for multiple treatment options where a direct comparison is impossible without using this systematic review and analysis.

Do you really know how to deal with conflict? Conflict is one of the biggest topics of stress at work. Managing conflict gives a huge drive to our success and satisfaction at work but in reality, it's really a challenge to manage it. Today, we give you the recording of a webinar with Gary on how to effectively resolve conflict without giving in and you'll learn about these points:

How do we develop new medicines to treat nasty diseases? It all starts by discovering a novel target molecule in the lab. Fast forward 12 years and an average expenditure of 1.5 billion dollars we hopefully get the thumbs up from health authority bodies to license the medicine for public use. So we skipped a lot of important steps there. The journey for developing new medicines is extremely lengthy and complicated. Fortunately, you can listen to this podcast and know all the important stuff in 20 minutes! Statisticians are involved in all aspects of drug development. Having knowledge of the process from start to finish is important, as it will help you understand why statistics is an essential and relied upon toolkit in this industry. - Quick overview of the drug development process - Where and why statisticians add value in the process - Key stakeholder interactions - who do statisticians collaborate with?

What are the bigger trends in the biopharmaceutical industry, which will have an impact for statisticians? . . . in terms of technology changes? . . . in terms of regulatory changes? . . . in terms of political/society changes? What can statisticians do to prepare for these changes?

Why is text mining so important? What are the typical challenges and research questions in this area? Are there any ones typical for medical/pharmaceutical research? What data sources could we tap into? What are some foundational concepts in natural language processing?

What can you learn from Leanardo Da Vinci on how to put things into perspective? Do you struggle with learning about data communication? How important is data visualization? Storytelling is one of the great leadership things that play a role in communication. Through stories, you can get the alignment, you can influence others, and you can have an impact on others. It's one of the pieces of a puzzle to be an effective statistician.

What can you learn from Leonardo Da Vinci on how to put things into perspective? Do you struggle with data communication? How important is data visualization?

Do you have great ideas but struggling to implement them? Is having an idea and just being right already good enough? What can you do to convince your supervisor? How can you help others understand your point of view? Do you have the right tools on how to make things work? In this episode, I'm speaking with two members of The Effective Statistician Leadership program. One is coming from academia and one is from a pharmaceutical organization - they both have interesting and inspiring success stories.

Do you have what it takes to be a leader? What skills can you learn from the leadership program? What is the mastermind concept? How can the leadership program help you become a better influencer? In this interview, I’m speaking with two leadership students, Sam and Ludi, on what they have developed throughout The Effective Statistician Leadership program. You’ll learn a lot about how leadership helps you to achieve your goals at work and how it also helps you to increase your job satisfaction.

Have you thought about being a leader? Do you feel responsible or afraid of taking the lead? Are you equipped enough to be one? Our definition of leadership is the ability to consistently deliver value to an organization or a cause by inspiring others to take a specific direction or action when they truly have the freedom of choice to do otherwise.

Do others not help you? Are they making your life hard? Is your company bad? Does your compound suck and hinders your work productivity? A lot of people complain about almost everything. Statisticians tend to be more on the introvert side and there are discussions that introverts are more likely to have a victim mentality.

Frank has something in common with Benjamin and myself - we all studied statistics in Göttingen and learned and researched in non-parametric statistics. Afterwards, we went into different paths. Whereas Benjamin started at a CRO and I joined large pharma organizations, Frank continued on the academic track. He recently became Professor at the famous Charitee in Berlin, where he’s still dedicating a lot of research to the field of non-parametric statistics. However, he’s not an ivory tower researcher but also applies these approaches in the medical research he’s taking part in. Learn about a whole universe of different approaches, which will help you overcome many limitations of the methods, which you’re using daily.

Why do you think many of these “subgroup” projects are a headache for statisticians? Have you felt frustrations about such projects yourself? What are the steps to avoid or at least minimize these frustrations? Do you have the same questions in mind? These are some of the questions Necdet will be and sharing with us. This episode is based on a presentation at PSI 2019. Necdet won The Effective Statistician Best Presenter award for the amazing delivery of the presentation. But not only the delivery was excellent - the content will help you a lot.

Are you curious about why and how I started The Effective Statistician? What's in it for you? Why I'm passionate about it?

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 interesting aspect that may come up with such discussions. A lively debate followed about the differing needs of Regulatory agencies vs HTA, with the patient voice often not taking centre stage.

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 storytelling with data? - Why is it important? - Which role should statisticians play? - What skills do statisticians need for this? - Where to learn these skills?