The Effective Statistician - in association with PSI

Indirect comparisons provide evidence, when no direct clinical trials are available. However, the different approaches come with various limitations. Some more recent approaches take into account the baseline characteristics to reduce the bias in the estimates of the treatment effects. In todays episode, I'm talking with one the worlds experts on this topic - Nicky Welton - who has published extensively in this field. Starting from the basics of indirect comparisons we move into the most recent research in this area. These new approaches will help to better understand treatment effects in specific populations of interest. Possible applications run from designing phase II or III studies up to re-imbursement dossiers and commercialization efforts.

theeffectivestatistician.com Every statistician in the health sector must know about estimands and how to apply the estimand framework. In this episode we introduce the topic using a case study. We’ll cover How does the HTA system in Germany work? What are the 4 critical elements for the estimands framework? How does the application of the estimand framework differ in study planning vs post-hoc?

Today I'm looking back at the PSI conference 2018 in Amsterdam. You'll learn about my personal highlights and key take aways from the conference. I have also interviewed some interesting people from the conference for you to get some feeling about the atmosphere at this amazing event. In this episode, I'm covering the following episodes: Nupur Kolis key note speach in the plenary session about “The Future of Healthcare: Trends, Opportunities and Challenges“ Interview with Nelson Kinnersley about the workshop "Owning Your Own Development" The session "Not Just Another AE Table" with an interview with Maria Costa about "Personalised Benefit-Risk Assessment" The workshop "Learn How To Swing: Hands on Workshop on Preference Elicitation in the Age of Personalised Medicine" The session "Estimands Case Studies" The session "Gone in 60 Seconds (Poster Review)" including an interview with Jules Hernandez-Sanchez The keynote by Steve Ruberg about "Statistics and Data Science: Is Six the Same as a Half-Dozen?" The workshop "Improving Your Communication" The session "Patient Centricity" The session "What Matters Most? - A Scientific Advice Role Play" including an interview with Mouna Akacha The session "A Picture Says More Than 1000 Tables - Interactive Data Review" The session "Regulatory Town Hall"

theeffectivestatistician.com As a statistician we delegate all the time with programming being probably the most prevalent example. In this episode, we start by showing in two personal examples how delegation improves your productivity amazingly or how it can lead into complete disaster. Furthermore we cover the following questions: - Why is delegation so important? - Why are not only managers delegating? - Why should I delegate, if I can do it myself? - What task can I delegate? - How can I delegate appropriately? - Why are many people not delegating more actions? By listening to this episode, you will also learn about these 4 principles of delegation: - Any task should be done by the most junior team member possible. - Delegate tasks in such a way, that they are interesting for the people to work on. - Specify what goal you want achieved, defining together what a great outcome looks like and support as needed, but resist the urge to tell exactly how to achieve the goal. - Delegate deliverables not tasks The episodes concludes with a discussion on the how to create an environment where - your team members thrive, - you successfully reach great project outcomes, - people are motivated and engaged, and - both team members and leadership wins.

theeffectivestatistician.com In this episode we have our first non-statistician as a guest. Julia has build her own consulting and training company Zestfor. She and her team specialise in developing Training programmes and resources scientifically tailored for technical markets – including Pharmaceutical, IT, and Life Sciences. Getting things done through others is a key part or even the definition of leadership and her clients face often the same situation like statisticians. They need to convince people rather than commanding them. In this episode, we cover the following topics: - Why statisticians need to be more influential? - Is influencing actually something bad on inappropriate? - What characterises an influential person? - Which practices help statisticians to increase their influence? - Many statisticians are more introvert. As such, how can they deal with more extrovert business partners from other functions? - Relationships are key for influencing without authority. Trust is key for building these relationships. What can statisticians do, to generate more trust? - Networking is another aspect of building relationships. What actions to take to build networks? - Many of us work in virtual settings to some extent. This poses additional barriers on influencing others as it is much harder to be heard and understood. Which techniques can we apply to overcome these hurdles?

theeffectivestatistician.com In order to make new drugs available to patients in Australia, a successful interaction with the PBAC – the Australian HTA body is needed. Alan Brnabic lives in Australia and collected a lot of experience with these submissions over the years. In this episode, we cover: - the basics of understanding how the PBAC works, - why a successful PBAC submission is important, - what evidence is needed to have a successful PBAC submission, - how much work is needed from the statistician’s side for the PBAC interactions, - what are the typical challenges from the PBAC, - when is a good start to get prepared for the PBAC work, and - how is the data submitted to PBAC publicly available.

theeffectivestatistician.com In this podcast episode, we discuss an important part of leadership - proactive behaviour. Or simply put - drive! As a statistician, you’re day-to-day approach about this topic will build up to long-term success. We discuss various aspects of drive including: - how it relates to your goals, - what it takes to think strategically, - which role innovation has here, - what practical steps to take to drive teams forward, - which knowledge to acquire to lead teams successfully, - how this relates to influencing, - and how your attitude will play a big role in this.

Ok – not everything, but in this episode you will get all the tips to make sure, you avoid the most common mistakes and that your code looks professional. Shafi Chowdhury is an expert programmer who has developed a style guide, which his clients apply broadly. He regularly gives trainings on SAS programming and build his own company based on these skills. He walks us through the different points and clarifies, why they are important from an efficiency but also from a quality perspective.

theeffectivestatistician.com In this episode, we’ll cover an amazing story by one of the best programmers and mentors I ever worked with - Shafi Chowdhury (www.shaficonsultancy.com). We’ll explore how it changed from being a freelance programmer only to building his company on the side. He had a great vision in mind, that drove him forward. You’ll also hear about his approach to teaching and mentoring – or in general helping people do their job better. His abundance mindset inspires me a lot. Shafi explains, why and how he made his own job redundant in his own company. Retention is a major cost driver and disrupts some companies a lot. You’ll learn how he manages to have nearly no turn-over in his company and how is approach to recruiting and training new employees fits in to this. Further, we’ll cover how and why Shafi and his team is regularly presenting at different conferences. We’ll especially go deeper on this presentation at the PSI conference in 2017 about an amazing tool to analyse and visualize data at the same time. His approach to delivering all this innovation is very unique. Finally, you’ll learn a lot about the leadership attitude, that helped him grow his business fast into a medium sized CRO with a very stable client base.

In this episode we share out ideas and experience, which mindset sets up statisticians for success. We cover topics around: - Leading people - Convincing business partners - Delivering value and selling it - and what does selling means - Thinking outside the status quo to improve things in the long run - Always learning about the business and the people in the business - Learning about statistical innovation - Doing things more effectively - Becoming more impactfully - Raising your business acumen - internally and externally - Having quality in mind Quote of the Episode by Bill Gates “Most people overestimate what they can do in one year and underestimate what they can do in ten years.”

The guest in this episode represents the sponsor of this show - Nigel Howitt - current chair of PSI. After a short introduction of Nigel and his experience with PSI, we will cover the following topics: - How can someone, that is interested become a new PSI member? - What rules are there for students? - If you’re a data scientist in the pharma industry- is PSI the right association? - How to get most out of PSI? - What are the different ways, you can become more engaged within PSI? - How can you get involved with one of the PSI committees? - What’s the role of the SIGs and how do you get involved there? - What Nigel is recommending new members of PSI as first steps? - What are your highlights of the PSI conference in Amsterdam? Finally, we'll also discuss how to get most out of the conference.

In this podcast episode, we tackle a difficult topic for a podcast, but Zak provides lots of expertise in this field and will introduce you to what visual analytics is and how it will help you. Furthermore, we touch on questions like: What is the difference that visual analytics plays in 'exploring/learning' and 'messaging'? Why is visual analytics important? Why should I care? How does the job of a statistician in visual analytics look like? Is visual analytics purely descriptive and exploratory in nature? What does the future of visual analytics in the pharma industry will bring? How can you implement these approaches in your day to day work? What tools are there for beginners, people with decent programming or advanced programming skills? What are the other places to learn more about Visual Analytics? (IEEE VIS: InfoViz, SciViz, and VAST; Flowing Data; Perceptual Edge) What you can expect from Zaks presentation at this years PSI conference in the wednesday morning session “A picture says more than 1000 tables- interactive data review using visual analytics”

If we think of world experts, we often think of people, that are candidates for the Nobel prize. We tend to have the believe, that we will never be able to achieve such a status. Actually most of us probably don’t even think about getting to this level. This is why we are so happy to have Claire Brittain as our guest on the show. In an ordinary role of a statistician working in early phase, she has done outstanding work. Listen to her story of how she came to be called a world expert on Progressive Supranuclear Palsy (PSP), a rare neurodegenerative disease. This amazing story has lots of learnings for each of us. Finally, Claire will present a poster about her work at the PSI conference in Amsterdam. Actually, it’s not just a poster, but listen to the episode and you’ll learn what’s so special there.

In todays episode, we take a look into the future - the future of PSI and how it will impact you. Both candidates, that run for becoming chair of PSI - Lucy Rowell and Naomi Givens - speak about their vision in our interview today. Of course, this episode will help you to decide who to vote for, but it will also help you to understand how to benefit from PSI by becoming an active member. Both candidates share their stories of how they got more and more involved within PSI and how they were able to impact the world of statistics through PSI. In more detail, we’ll cover the following topics in the episode: Experience of the candidates with PSI Achievement at PSI and their current role on the board of directors for PSI Why do they want to become chair of PSI Changes to PSI, that the candidates would like to initiate The candidates visions for the future for PSI and how to get there

Do you have a lot of email ping-pong, where emails go back and forth many times – too many times? Are you aware about the brand of you, that you communicate with your email style? Is email your default communication tool? Then this episode is for you. We have researched various articles on good email writing copies and distilled the best for you in this episode. By listening to this episode, you will learn about: When is email the best way to communicate? Approaches to attachments. How to take care of your style? How to structure your emails? About different email cultures Simple actionable tricks to improve your effectiveness directly

Everybody uses email multiple times during the day and email represents a key communication channel. Managing the flood of emails effectively, will reduce your stress. In this episode, we discuss various approaches, that we learned over the years from different productivity experts. We discuss how we implement them in our daily routines. By listening to this episode, you’ll learn about these topics: What are helpful mindsets about emails Five step approach to managing emails Good habits to establish like Reply in a timely manner Send and respond less to receive less. Tips on how to set up filters Smartphone vs desktop email checking When and when not to work on emails And the option of last resort

Data science, big data, business analytics … these are all buzz words in the industry at the moment and the hopes are high on what these areas will provide to our industry. Cytel organized a long session about data science for the PSI conference 2018 in Amsterdam (learn more and register here). In this episode, we’ll speak about: Why is data science such a hot topic at the moment? How can we separate the different buzz words? Is this only something for google, amazon and such companies? What distinguishes a statistician from a data scientist? What are the biggest areas of impact for data science? What case studies are there, where data science had a profound impact? Which problems you might face? Which role do visualization approaches play in data science? What’s the difference between “machine learning” and “deep learning”? What would a statistician need to know, in order to compete in this field? Where are good resources for this (see also the Cytel blog here)? Finally, we will dive into the sessions, which Cytel chairs as the main sponsor of the PSI conference. You’ll learn if this session is a good fit for you. About Yannis Jemiai Yannis Jemiai has a pivotal role within Cytel, leading the company’s consulting and software business units, as well as the global marketing group. With Cytel Consulting he heads up an elite team of biostatisticians, skilled in applying the latest trial techniques and methods, to help our customers accelerate clinical development and mitigate portfolio risks. Yannis also oversees the development of Cytel’s software product lines, including trial design packages East® and Compass®, and exact statistics applications StatXact® and LogXact®. Yannis guides global marketing efforts to raise the awareness of and uncover new opportunities for the company's growing range of clinical research services and specialized software. His own research has been published in numerous statistical journals. Dr. Jemiai earned his Ph.D. from Harvard University, an M.P.H. from Columbia University, and a B.A. in Molecular and Cellular Biology also from Harvard About Rajat Mukherjee Rajat Mukherjee has 15 years of professional experience as an industry and academic statistician, and brings a range of expert knowledge to Cytel’s customers. This includes work in pattern recognition problems for devices and biomarker discovery, Bayesian clinical trials, adaptive designs, and design and analysis of complex epidemiological studies. His experience and expertise also includes statistical computing, survival analysis, longitudinal analysis, nonparametric and semiparametric inference, as well as statistical classification and high-dimensional data. Rajat has a strong background and interest in the development and implementation of statistical methodology with application to real life medical problems.

In this episode, we’ll cover Lucys story about her work within PSI and how it helped her to with her promotion. She shares tips and tricks to make it happen and we explore, what it takes to become an active PSI member. Lucy is the conference chair for the PSI conference 2018 in Amsterdam. As such, we also talk about various hurdles and benefits of running such a large event. Lucy explains what you can expect from this years conference and how learnings from previous conferences are implemented. Learn more about the details of the program etc and register for the PSI conference 2018 in Amsterdam here. About Lucy Rowell Lucy has been an active member of the PSI Scientific Committee for 6 years and this is her final year as the conference chair! Lucy is currently embarking on a 50% rotation into the UK Affiliate, supporting early pipeline molecules, from either a Medical or Marketing perspective. During her 15 years at Roche, Lucy has enjoyed a 6 month secondment to the US and worked in a number of disease areas including: inflammation, virology, metabolism, infectious diseases and oncology projects, across all phases of clinical development and has been involved in designing a wide variety of trial designs implementing both frequentist and Bayesian approaches. When not in work, you will most likely find Lucy out listening to live music, walking her dog Buddy or curled up on the sofa reading a good book with a glass of vino.

Are you afraid of asking your supervisor for approval to travel to Amsterdam to attend the PSI conference? Do you need convincing arguments for them to approve your travel? In this episode, we talk about arguments, that help you in your discussion with your supervisor. We're talking specifically about the PSI conference 2018 in Amsterdam, but these points will very much be applicable for future PSI conferences as well. You probably don’t want to tell them, that Amsterdam is a very nice city and the social activities will be lots of fun. But here are some arguments, that might help you to get the approval: The conference is highly relevant to statisticians in the pharma industry. There are no ivory tower research sessions with little practical applications. All the topics were selected having statisticians in the pharma industry as the target audience in mind. 3 days packed with specialized content. Many of the sessions will help you to work more effectively in your job with higher quality outcomes. You will learn how other companies solve the same problems that you have. The vast majority of speakers are very experienced presenters, that will enable you to learn much more in shorter time. Lots of work is put especially into the many invited sessions, to compose the different presentations and give you a holistic experience of a session rather than a collection of vaguely related topics. There are a number of workshops during which you can learn hands-on skills to apply directly to your work. E.g. you can participate in a development and coaching session targeted especially for statisticians (not a general one, that any training company offers). During the informal breaks and at the social events in the evening you may meet with your clients (if you work for a CRO) or your vendors (if you work for pharma) and build relationship and trust. This will make current or future collaborations much easier. Alternatively, it may help to build future business relationships. Are you working on regulatory or HTA submissions? Many sessions and workshops will cover hot topics and after attending them, you will be better prepared for your high-impact contributions to these critical submissions for your business. You will also meet some staff from the HTA and regulatory bodies at the conference. Do your business partners don’t understand what estimands are? Do they have a hard time to understand the Bayesian concepts that you’re applying? Learn at the conference to better communicate about these topics from industry leads on these fields. This will help you to be more impactful during critical conversations with your business partners and you can provide examples of how others in the industry are solving problems. #8 Do you have a formal development plan? Put it in there and your supervisors will be happy that there is already something ticked for their HR deliverables. And if this is in-line with your business objectives – even better. The conference is cheap compared to a DIA meeting or any international medical conference. Take further advantage of the early bird discount rate up to the 21st March 2018. You have a poster to be presented at the conference. Ok – this only works, if your supervisors approved the submission of the poster. But it is always something for them to sell upwards, that you’re an active contributor. The poster deadline is the 28th Feb 2018. Not every reason will work in every situation and with every supervisor. Try to understand, what goals your supervisor has and tailor these arguments towards these goals. Register and find out more about the conference here! Do you have more reasons to attend? Please leave a comment below.

In this episode, we discuss our experiences in working with various programmers and what we as statisticians can do, to create an environment, where we can work without major disruptions and too many stressful moments. We’ll cover topics such as: How to increase mutual understanding How do delegate well The balance between specifications and workload Day to day activities to make life better

In this episode, we speak about one of the most important work relationships – the one with the physician. As a statistician we work with them in all kind of things on the job. They also might become great friends. In the episode, we will cover the following topics: Topics to increase the understanding where the physician is coming from such as How was he successful in his previous job – e.g. emergency room setting with command and follow setting to solve urgent crisis Hospitals and physician’s offices are built with the physician at the center as he is the bottle neck Has he even been a KOL before joining the company – that’ll make it hard for him to switch to a new culture Mindset and tactics to create a successful partnership such as Have 1:1s in which they you can answer their perceived “stupid” questions be a partner and not a service provider Present data together with the physician and show him, how you both can benefit How to become a more valuable partner to the physician by e.g. Provide draft conclusions based on analyses Learn his language as you encourage him to learn yours Have a physician as a mentor to learn how to best work with them Tips on how to give the physician insights into your job and that it is not a push the button exercise

In our first episode, we talk about who is writing and talking here, if this podcast fits your needs and will help you, how the podcast will boost your career, and what our approach to podcasting is. Who is writing and talking here? We’re Alexander Schacht and Benjamin Piske. We create and edit the content, in addition to managing our work lives, home lives and being continuous learners. We invite you to come and learn along with us to work more effectively, lead courageously, and solve problems innovatively. Alexander Schacht I have studied mathematics and received my PhD in biostatistics on non-parametric statistics from the University of Göttingen in Germany. I authored more than 70 scientific manuscripts in peer-reviewed journals and regularly speak at international conferences – both statistical ones like PSI and medical ones like EADV. During my career at university and within the pharma industry, I have collected more than 20 years of experience. My career focused mostly on phase III and IV (RCT, observational studies, HTA submission, commercialization work) with some regulatory work as well as some experience in the early phases of clinical development. I’m interested in a broad range of methodological areas but specifically on making better decisions based on data. As such, I was the chair of the EFSPI/SPI SIG on benefit-risk for some time. PSI provided my with many more opportunities, which I’m happy to work on. At work, I supervise of a small but mighty team of statisticians in a large pharma company. The virtual work environment requires me to adjust my communication style and focus on my ability to deliver results effectively. I’m a happy husband and father of 3 wonderful kids, who I love to spend time with. In the rest of my time, I love running and listening to podcasts. Benjamin Piske I got interested in statistics during my studies of mathematics at the university of Göttingen when I attended courses of statistics at the department of medical statistics. Focusing on non-parametric statistics, I completed my MSc in 2003 and continued to work at the department until starting with a global CRO in April 2004. I started as biostatistician in the phase IIIb/IV environment and worked on interventional and non-interventional late phase trials, commercialization work, publication / presentation support, registries and investigator driven trials in several therapeutic areas - mainly oncology, hematology and neurology – using a broad range of statistical methods. During the later stages of my career I also worked on phase II and phase III trials as well as submissions. In 2008 I took over line management responsibility for a primarily remote team, and since then developed more and more into a senior position. I’m primarily working office based in our office in Berlin, Germany. Besides the challenging job and the not less challenging family responsibilities with having 4 children, I love to travel, occasionally play squash, but more frequently record podcast episodes with Alexander :-) Learn more about us in our first episode of the podcast and check out our linkedin profiles: Alexander Benjamin Is this podcast for you? The Effective Statistician helps statisticians (or maybe data scientist) both at a junior and experienced level. We’ll cover topics relevant for those with and without administrative leadership positions. Our examples arise from the health sector mainly, but we assume, that statisticians or data scientists outside of this industry will surely benefit as well. How will this podcast boost your career? Learning and following up on the topics in our podcast will help you to become more effective at work through: learning about ongoing methodological discussions Applying better statistical methods building competency becoming a leader (with or without an administrative title) Influencing without authority Building your brand Getting the right things done effectively Collaborating effectively with