The Effective Statistician - in association with PSI

What is medical affairs? Launch and Lifecycle? How has this area evolved over the last 2 decades? What is the current state across the industry in terms of the role of statistics in this space?

When there is one topic, which is really hot, it's causal inference. I've got in contact with it about 20 years ago when analysing observational studies and when nobody working on clinical trials would consider it. But now - after the introduction of the estimands framework - this becomes part of every statisticians toolkit. Today, we have one of the world leading experts in this field as a guest - Miguel Hernan. I'm talking with him about: How can this help generate and analyze data to identify better strategies for the treatment and prevention of both infectious and noninfectious diseases?

The guest in this episode represents the sponsor of this show – Nigel Howitt – current chair of PSI.

In the modern workplace, conflict has become a difficult topic. After all, conflict is antithetical to teamwork, employee engagement, and a positive company culture. Or is it? "No" is a sign of conflict and many avoid saying it by all means. But... Why is saying no so hard? How do we say no in the right way? When should we say no?

Subgroup analyses in combination with data visualisation is one of the hottest topics I can think about. And it hits us as statisticians during our careers again and again. We need to understand subgroups for efficacy reasons and safety reasons and it's a common question in terms of how consistent your drug works across the different subgroups. It gets even more complicated if you want to review it across multiple studies.

Publishing data is great, but we also want to measure the impact our work has beyond the additional entry in our CVs. During this episode, Mike and I discuss the tools Altmetric and Dimensions. These can help us to understand the reach and influence of clinical and scientific research beyond citations. Based on these, we can track the full journey, from idea to impact. We touch on a number of interesting topics during the interview, including how Altmetric and Dimensions work together in uncovering this journey, but also the insights that can be gleaned from the kind of data the tools provide. ‘I get to sit in the middle of this wonderful web with both Dimensions data and altmetric and I pull the two things together. And together, I can create these translational maps of where research is going from the laboratory through to the hospital and into the broader population.’ - Mike Taylor

We leverage Real World Evidence in many different areas and there's are many different things that can go wrong with this. In today's episode, Rachel and I will discuss the things that we would like to have known before we started working with RWE so stay tuned to avoid mistakes we made in the past.

How do you start your week? Do you just rely on yourself or do you use some tools to organise yourself? learned a lot of productivity hacks from Michael Hyatt. I've listened a lot to his podcasts and I used some of his recommended tools to make my plans work such as the Full Focus Planner which is kind of a calendar and a to-do list together with goal setting tips and more.

There's a lot of community charity works we can all do but there is not a lot of work where we can maximise our impact by using our specific skills as programmers, as statisticians, and as data scientists.

What kind of leader do you want to be? What are the leadership principles? I learned about the concept of leadership principles from Gary Sullivan and it helped me to better understand what kind of leader I want to be.

I've been working on RWE most of my career and the clinical trial data for a while now. And 20 years ago, we would have never thought about merging them together but there's a lot of opportunities if we do this. The recent advances in analytical methods for combining evidence from RCTs and non-RCTs, and the development of new frameworks for the inclusion of RWE in HTA have provided a greater insight on how issues around RWE uncertainty can be dealt with when estimating treatment effects for new technologies.

This year's PSI conference will be face to face again. I'm really excited for this. This is the best conference for statisticians that you can attend. If you are working in health care industry, there is no other conference like this. Attend this conference and meet friends and create new social connections! And you submitting a poster for the conference would be best!

During my early years, I was overwhelmed by so many trainings, SOPs, and processes. Only after my later years I learned what quality is really about. Gary fundamentally helped me and many others have a very different and more insightful/helpful/easy perspective about this topic.

What are typical data science methods that we are not yet using enough? Which areas will become important in the future in terms of data science?

Data visualisation is one of my favorite topics and today, I'll be interviewing someone who has helped me understand about data visualisation for years.

Is it possible to align business focus and self development at the same time? How can we create clear department or company goals or relate these to our goals?

I've been in pharma for 19 years now. I worked in various areas mostly in late phase area - post regulatory approval and phrase 3. I worked in different big and mid-sized pharma companies and worked in local, European, and global organizations. I've seen a lot of things in different areas and I learned a lot what works and what didn't work so well in pharma. I have learned a lot and now I want to take the next step. I want to impact the decision-making. I want to improve how we communicate with physicians, payers, and patients in a much better way. I want to help this area and I cannot do that in one company - so that's why I moved to a CRO: Veramed.

What is the Enneagram? How will it help me work more effectively or be less frustrated? Lots of statisticians are introvert and detailed oriented. Does this imply, they will be largely in specific Enneagrams? Willene left the IT industry after 20 years and subsequently qualified as a Life Coach. She is a PCC (Professional Certified Coach), accredited by the ICF (International Coaching Federation). She's also an accredited Enneagram Practitioner and certified Genos Emotional Intelligence Practitioner.

Over the last years, leaders of statistical organisations across Europe are meeting each year to talk about how the community can be moved forward and other important topics affecting statisticians in the industry. In 2021 was another meeting and I'm talking with Chrissie Fletcher about some of the topics covered during this years meeting.

In our standard graphics, we usually present summary statistics only. The exception is the Kaplan-Meier plot showing also individual patients. Showing individual patients effectively tells us so much more about e.g. clusters, outliers, and extreme values.

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.

Have you ever been stuck in moving something forward? Do you wonder why others seem to be able to cut through the bureaucracy more easily? Are you frustrated by the politics around you?

Olaf has a really interesting character. He is an IT guy and he went up through the ranks of different companies, had a great career and learned quite a lot about leadership. He was applying a lot of these learnings and now he's training others in that regard as he has his very own leadership program. I'm a participant and have benefited a lot. One day, we agreed to discuss the 4 pillars of boosting your career. He helped me sharpen my thoughts and here's the result!

What is Statistical Engineering (SE)? How did the idea of Statistical Engineering come about? Is SE an idea and a practice, or is it a profession, or both? How does SE compare to the role/profession of “statistician” and/or “data scientist”?

Today, I have an interview with Margaret Gamalo, about how to combine a controlled arm with real world evidence data, a really hot topic. Also, Margaret has been sharing her knowledge for a long time and has gained lots of opportunities this way. Helping others will help you in the long-run. We discuss this aspect in the episode as well.

Are you overwhelmed by work? Do you feel like being constantly under time pressure? As I’m talking with colleagues in nearly all organizations, there seems to be an overall increase in workload, shorter timelines, a reduced number of people to help, and also an increase in complexity of the projects. This leads to the breakdown of the system. There’s some interesting research by a German mathematician, who wanted to understand why the German railway system sometimes completely breaks down and delays accumulate quickly over the day.

Do you want to help someone improve their visualization skills? Or do you want to train others on any other statistics skills? Training is a very important topic for us statisticians. We train people all the time it can be about statistics or non-statistics.

Is it possible to align business focus and self development at the same time? How can we create clear department or company goals or relate these to our goals? In this episode, Benjamin talk about how to make business focus and self development work together. We also provide you numerous tips on how to make it work.

While we go through our career, we have lots of days that are more or less similar: meetings, discussions, and emails. But sometimes there are spotlight moments. You can be in a meeting with various senior people or work with new clients that is really critical. You have a meeting that will make it or break it. Very often these kind of meetings come with some kind of warning. You e.g. know you need to defend your case in front of a committee and it will be a tough discussion. One of the toughest discussion you can be in as a statistician is a GBA hearing in Germany. During this meeting you can make or break the launch of a new product or indication in Germany with consequences for Europe and beyond. As a statistician you're here in a high stake discussion.

What is a statistical unicorn? What should we be doing to become one? Gary Sullivan introduced me to Ena and she's a really interesting statistician. She was actually quite ahead of her time when she founded her CRO.

What are the limitations and strength of introverts in negotiations? What does listening really mean and why is it important for negotiations? How do to handle different emotions during negotiations or emotional hijack? How to extract intel from without being obvious? It is important to be an effective negotiator as negotiation is all around us all the time. Whether it's about daily life or making decisions at work as statisticians. But at as experts in this field (and being mostly introverts), we need several skills to develop and grow our negotiation skills.

What is Dark Data? What inspired David to write this book? What did he hope to accomplish in its writing? Today, we all make decisions using data. Dark Data shows us all how to reduce the risk of making bad ones.

How does data visualization work for journalism? What can we learn from it as statisticians? Today, we will be talking about data visualization in journalism with Irene. She has worked for BBC so she has a background with journalism and we will learn from her perspective.

Are you looking for a promotion or a higher salary? What are the processes to grant these kind of requests? Can you ask for this right away or is there a specific timing? When I started my career, I had no clue about this topic so I made a lot of mistakes and learned it the hard way. The right approach to this depends on number of things. One is considering the size of your company. If you are in a small company, the chance of directly negotiating with the owner of a CRO is bigger than the big companies. While in bigger companies, you need to undergo a certain process in the HR department.

What is a good or bad strategy? What is the difference between strategy and goals? Has strategy something to do with vision or long-term thinking?

What is due diligence? Why do you need a statistician in it?

Afraid of speaking up? Afraid of talking to senior management? Afraid of giving a presentation? Afraid of speaking to someone new? Then you are definitively not alone. Many supervisor worry about their staff not speaking up and I have come across even senior statisticians, who are very uncomfortable about doing a pre-recorded interview for the podcast.

How do you create and teach effective and moving content that your audience will pay attention to and add great value to them? Teaching is really important to us statisticians because we need to explain stats and data all the time to our colleagues, within stats or outside stats.

Is having a mentor really beneficial? What is Manatee Mentor? What are its key features? How can this predict your professional success? Manatee Mentor is an AI-powered platform to make mentoring inclusive, affordable and accessible to all. It can match or unmatch with your mentor and mentee through its constantly learning AI algorithm. You can choose your topic of mentoring, preferences, and find your perfect match in few clicks.

What is the data project? Why are data management programs a strategic imperative? Why do they fail? Usually a data management project starts with a change of perspective in the organisation, especially from senior leaders. To make such a project happen, data leaders must be familiar with the principles of change management, learn to speak the language of business, and be excellent listeners to craft and communicate an interesting and realistic vision to release value from information.

You may think that QR codes aren't new. But it's actually quite something new in our field. We as statisticians, should not just leave the use of QR code to other functions such as medical writing. Instead, let's leverage this tool to have an impact and improve our output.

Today, we have a special guest, Shanti. Learn while she shares with us her vast experience in the pharmaceutical industry collected over 25 years. She held various positions inside and outside of statistics organization.

When I started my career as a statistician in the clinical world, I was wondering about safety analysis. I thought it's always the same - count the patients with an event - job done! Then just repeat. But it's not that simple, especially in more complex situation where you have different follow-up times. Then the patients that stay longer on treatment as they benefit from it, also get more adverse events. Naively counting the patients with events or the number of events may make the beneficial treatment look worse. So, how can you account for this?

Why spend part of your career in non-clinical statistics? What are the advantages? What is the importance of having a variety of tools?

R versus SAS - which is a better tool? Today, we talk about a controversial topic. If you go online and look into social media, you'll find a lot of data scientists that talk about R versus Python. In medical and clinical research, it's more about R versus SAS. For this discussion, we have Sam Gardner and Thomas Neitmann representing SAS and R, respectively.