Best Alexander Schacht And Benjamin Piske Biometricians Statisticians And Leaders In The Pharma Industry Podcasts (2023)

Interview with Shirley Wang The story behind RCT DUPLICATE and how it was developed to facilitate research The approaches taken in conducting these studies. Predictions on how future advancements will affect the development of new therapies. Listen to this episode and share this with your friends and colleagues!…

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Deep Work 24:10

14d ago24:10

24:10

By Alexander Schacht and Benjamin Piske

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The Effective Statistician - in association with PSI

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The Single Arm Studies and What are the Alternatives? 51:41

9d ago51:41

51:41

Interview with Anja Schiel Are you seeing a return to single arm studies from an HTA perspective? What potential drawbacks should be considered when opting for non-randomized comparative trials instead of randomized control ones? If a full RCT isn't feasible, what other viable approaches are available as substitutes? How can sponsors best communica…

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3 Steps to Make Your Research More Reproducible 35:08

30d ago35:08

35:08

Interview with Heidi Seibold Document Everything Create Reusable Code Share Results with Others Making sure that your research is reproducible is important in the pharma industry because it allows others to understand what you have done and how you arrived at those conclusions. By following these three steps—documenting everything, creating reusabl…

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What will be the role of health economics in the future EU HTA? 36:40

29d ago36:40

36:40

Interview with Katrin Kupas and Jen Min-Hua The EU HTA will not only affect all statisticians in the pharmaceutical industry with respect to skill sets and collaboration (we talked about that in podcast #3), but will also have an impact on the economic modeling that is needed for the reimbursement and pricing decisions in many European countries. U…

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Future implications of EU HTA and how Next Gen get involved 24:39

1M ago24:39

24:39

Interview with Katrin Kupas and Dr. Arthur AllignolAll statisticians in the Pharmaceutical Industry will be impacted by the new EU HTA regulation. Activities around HTA submissions will happen earlier than currently, in parallel to the regulatory approval process for marketing authorization. There will be an increased scope of evidence for the join…

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The Recent Alzheimer Story - an absolute low for the industry and especially for statisticians 30:50

1M ago30:50

30:50

By Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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The Effective Statistician - in association with PSI

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What is the role of estimands in the EU HTA? 24:54

2M ago24:54

24:54

Interview with Dr. Arthur Allignol and Anders Gorst RasmussenIf you’re a statistician working in a regulatory setting, you’re probably familiar with estimands as a way to frame the clinical question of interest. But what’s the role of estimands beyond regulatory approval, in a Health Technology Assessment setting? That question is especially import…

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The first conference of The Effective Statistician 20:17

2M ago20:17

20:17

Bonus Episode The Effective Statistician will be hosting their first full conference on April 25th, 2023 as a virtual event. The conference is free to attend and will be five hours long, with a variety of presentations ranging from 15-20 minutes each. Some of the topics that will be covered include estimands, bayesian approaches in early developmen…

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What is EU HTA and why should statisticians care? 41:09

2M ago41:09

41:09

Interview with Lara Wolfson and Anders Gorst-Rasmussen References: D4.5 - EUnetHTA Antonia Morga, Nicholas R. Latimer, Martin Scott, Neil Hawkins, Michael Schlichting, Jixian Wang, Is Intention to Treat Still the Gold Standard or Should Health Technology Assessment Agencies Embrace a Broader Estimands Framework?: Insights and Perspectives From the …

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What is the ASAP and what you should know about it 29:04

2M ago29:04

29:04

Interview with Greg Ball The US FDA has been advocating for aggregate program-level safety evaluations since 1988 when the ISS was introduced (the IND Safety Reporting Final Rule). Aggregate data analysis looks at all available data holistically rather than relying on individual case reports. This allows for a more complete understanding of potenti…

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6 Problems Around Creating Data Visualisations 18:08

2M ago18:08

18:08

Just relying on a simple table without data visualisation Not taking context (message, audience, circumstances, channel) into account Lack of testing with the target audience Having an unclear message to start the design Incorporating every comment Relying heavily on templates Listen to this episode now and share the link with your friends!…

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What You Can Expect in 2023 From Me 26:05

3M ago26:05

26:05

I share with you about my consulting job and how great it is to work with different, awesome people across the industry How I help companies streamline their and automate processes The Effective Statistician Academy and its two parts Leadership Training Publication work other webinars and courses Listen to this episode now and share the link with y…

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Leadership Characteristics of Exceptional Leaders 31:57

3M ago31:57

31:57

Webinar with Gary Sullivan Statisticians are trained to be leaders and have many of the skills required for leadership positions Statisticians can use their problem-solving, questioning, and decision-making skills to help resolve issues within an organisation An example of how a statistician's leadership skill can be used when there is a case in ma…

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The Effective Statistician - in association with PSI

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Why you should be more active on LinkedIn 14:10

3M ago14:10

14:10

Find recruiters and search for the right candidates Find new companies Grow your network Get motivation and be on trend Showcase your expertise Build your brand Other ways to maximize LinkedInBy Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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The Effective Statistician - in association with PSI

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First mover advantage and how it applies to statistics 23:11

4M ago23:11

23:11

First Mover Advantage gives the statistician the power to direct development and growth in relation to the creation of new solutions to problems that arise in the beginning and even in the third phase of the research before they are released for actual application by pharma companies. The consideration of the first mover advantage requires that a s…

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By country analyses for clinical trials and observational studies 15:52

4M ago15:52

15:52

Finding a common ground among the countries involved and using it to establish the foundation of the study. Using the common ground as a basis for the variables that are to be used for sample measurement and analysis. Improving how data is balanced between differences to create a singular and focused outcome. Considering removing countries that do …

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Leadership - what it means, how we built it, how it will help us shape the future of statistics 40:58

4M ago40:58

40:58

Interview with Alun Bedding Get formal learning about leadership and reflect on it Get a professional coach to get proper guidance and feedback You learn by being proactive and by practicing the 7 habits of highly effective people Deeply know your WHY before you start leading your team (see the book by Simon Sinek) Review the fundamentals of leader…

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Answers to 7 questions you probably have about improving your presentations using stories 40:53

4M ago40:53

40:53

Interview with Helen Packham Developing rapport with the audience is critical to convincing them that your message is something they can use. Storytelling does not need to be in depth, but it needs to be connected with the topic that you are going to discuss in the presentation. Storytelling enhances the way you connect with your audience through g…

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Multitasking 23:49

5M ago23:49

23:49

Multitasking destroys your productivity more than build it up. Focus takes practice before it gives you the outcome that you want from the tasks that you give attention to. It is best to complete one task after another instead of doing them all at once. Statistical research requires focus for them to be analyzed with full accuracy. Understanding ho…

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Practical steps to improve your leadership skills 45:31

5M ago45:31

45:31

interview with Gary Sullivan In terms of courses, we specifically dive deeper on The Effective Statistician Leadership Program. You can find more on this program information here!By Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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5 use cases for network meta-analyses you should know about 25:27

5M ago25:27

25:27

Interview with Daniel Saure Understanding your phase 3 data Understanding competitive data Critique Published meta-analyses HTA submissions Reevaluation of Price Here are some lessons you can get from this conversation: You need to frame your data and measure the success of your product or your studies and protect the information to avoid any explo…

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Bonus Episode: Understanding leadership deeply – trust, relationship, and influence for statisticians 37:04

5M ago37:04

37:04

Interview with Gary Sullivan We don’t stay general and speak about specific examples, including negotiations. After listening to this episode, you will have a solid understanding of the levers of success, that is not associated with technical knowledge. This is the first part of the interview with Gary (check here for part 1).…

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R and its rising role 32:29

5M ago32:29

32:29

interview with Coline Roche Using the R Strategy to improve the way teams work towards a singular focused goal. Improving how teams are directed and delegated in tasks where they can perform best. Using internal leadership alignment to help key persons become more effective in their assigned posts. Head on to the podcast, listen to our conversation…

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Leaders are persistent 16:51

6M ago16:51

16:51

Persistence helps break the barriers between statisticians and their stakeholders With the right persistence, statistical clinical research can lead to remarkable changes in healthcare Persistent leadership drives more effective results that bring efficient adjustments With persistence comes conviction, making every leaders statistician be convinci…

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Why should statisticians care about leadership and developing their leadership skills? 29:03

6M ago29:03

29:03

Interview with Gary Sullivan What is a good definition of leadership? Why should technical statisticians worry about developing leadership skills? What happens, if you have limitations in your leadership skills? What should the mindset of a statistical leader be? When should statisticians start thinking about developing their leadership skills? Lis…

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RWE and the FDA (Part 2) 24:44

6M ago24:44

24:44

Interview with Josephine Wolfram RWES are collected through statisticians actually getting involved in the collection of data through interview, survey, and feedback questionnaire from both physicians and patients. Validation of data should be accomplished through focusing on the accuracy of the representation of the data from actual settings and h…

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Bonus Episode: Impactful influencing: actionable advice to get things done through and with others 32:20

6M ago32:20

32:20

Interview with Julia Carter Why do statisticians need to be more influential? Is influencing actually something bad on inappropriate? What characterizes an influential person? Which practices help statisticians increase their influence? Many statisticians are more introverted. How can they deal with more extrovert business partners from other funct…

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Small pond big fish 39:35

6M ago39:35

39:35

Kimberley Hacquoil Statisticians’ contributions to change is increases when they get involved with smaller crowds. Statisticians working with smaller groups or agencies are required to develop better communication skills so they can easily collaborate with their teams and their superiors and actually drive goals towards extensive developments. Effe…

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As a statistician – do you take the back seat or do you drive yourself? 23:55

6M ago23:55

23:55

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.By Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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RWE and the FDA (Part 1) 35:34

6M ago35:34

35:34

Interview with Josephine Wolfram RWEs are dependent on actual patient reaction and response data collected through records provided by the healthcare agencies RWEs are viewed differently by statisticians and the FDA which may create friction, especially in the process of having one medication submitted for approval and production. and more... Lear…

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Success starts in your head – thoughts about the mindset of a successful statistician 26:50

6M ago26:50

26:50

Bonus Episode 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 Rais…

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Adherence – what is state of the art now? 34:05

7M ago34:05

34:05

Interview with Lina Eliasson Patient adherence is affected by different surrounding factors in the lifestyle and personal perspectives of the patients involved in a clinical trial Technological innovation makes it easier for patient adherence to progress; however, implementing these technological inclusions may present challenges to researchers. He…

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Stepping outside of our functions as statisticians with your career 30:13

7M ago30:13

30:13

Interview with Liz Thompson What are you good at? What are you passionate about? What can you do to add value to the society? Statisticians have all the necessary skills to make things happen and they should try to find an option to make such changes happen by standing up and getting out of the office to engage with people and organizations that re…

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Leaders invest in themselves 21:21

7M ago21:21

21:21

Leaders never stop learning even from their subordinates Leaders invest in themselves in sharpening their tools, their skills and exploring possibilities for growth Leaders get along with change and move forward by adjusting to the demands surrounding their profession. Leaders thrive in finding more solutions in the face of limitations and barriers…

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Publications in launch and lifecycle 42:58

7M ago42:58

42:58

Interview with Jenny Devenport 1. Publication is a critical part of the scientific process, It is important to communicate the results Peer review still adds credibility to research Important for further steps Need to have transparency - refer to clinical trials .gov History of not publishing data in the past 2. Helps establish credibility with var…

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What makes a great secondary paper? 41:04

7M ago41:04

41:04

Why does CONSORT not fit with a secondary paper? Tell a good story Make the story aligned with the overall strategy The 3 times 3 rule for a good paper The importance of good graphics Why do non-standard analyses help often Leveraging the appendix Further use of the paper Connection to abstracts and posters Working with co-authors Listen to this ep…

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What makes you feel comfortable is what keeps you stuck 18:08

8M ago18:08

18:08

Reasons for staying comfortable Fear of rejection Fear of failure Fear of not meeting expectations Unfair comparison to others Not being ready Being too busy Not important Set systems to reach your goals You can reach incredible goals Do something different Grow personally Vulnerability InnovationBy Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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Building organisations of leaders 41:07

8M ago41:07

41:07

Interview with Claude Petit We talked about the following points: What got you interested in leadership? What means leadership to you? Why is leadership important for us statisticians? What would a statistics organisation look like, if it would be very strong in leadership? How can we build such an organisation of statistical leaders? What's your #…

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Working with a pharmacometrician 24:41

8M ago24:41

24:41

Interview with Sree Kurup In this episode, we talked about the following points: What is the role of a pharmacometrician in the development of drugs? Besides statistics - what other functions do pharmacometricians work closely together with? Where are the touchpoints of pharmacometricians and statisticians? What is your experience of how both funct…

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Network Meta-Analyses: Much more than a press-the-button exercise 24:58

8M ago24:58

24:58

Some of the input data is missing for some studies. How do you deal with these missings - just exclude them? You compare many treatments with each other in a pairwise way. How do you best communicate this large matrix of pairwise comparisons? You need to adapt your NMA last minute because there was a delay in the system and your systematic literatu…

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Training in launch and commercialisation 37:24

9M ago37:24

37:24

with Jenny Devenport Why do non-statisticians need training in what they're interested in and why do they need to understand statistics? Why is a multi-channel approach really needed? What can we learn about the importance of the interactions between statistician trainers and non-statistician trainees? When conducting training, how must we decide w…

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Recruiting and retention in a post pandemic world 56:15

9M ago56:15

56:15

Webinar with Emma Adams Listen to this webinar while Emma and I talk about exploring the resulting recruitment challenges in a post-pandemic world within Life Sciences as a sector, also specifically within statistics across the UK and Europe. We confront recruitment challenges, as well as taking a thorough analysis into what Statisticians want—how …

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The best sources for RWE that you may never heard about 25:27

9M ago25:27

25:27

Interview with Anders Berglund ```We discuss the following points: What brought Anders into RWEWhat makes Nordic countries special when it comes to health system?What are some key success factors of the Nordic health system?What kind of population registers are there?and more… Reference:Epistat Nordic Registries```…

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Why and how to build your personal Board of Directors 27:27

9M ago27:27

27:27

Interview with Heather Melius We also talk about the following points: How have you learned about the concept of your personal board of directors? Why should we have one? What worked and didn’t work as you built your own board? Do you have an example of where this board helped you? How does it evolve over time? References: 4 Steps to build your per…

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9 presentation mistakes to avoid 25:48

10M ago25:48

25:48

In today's episode, Benjamin and I review 9 mistakes we often see during presentations. We'll talk about: Start with an introduction of yourself Wordy slides Monotonous Not speaking to the audience Hiding on stage Reading from the slides Not creating emotions Too much content Bad ending If you want to learn more about how to improve your presentati…

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Biomarkers - essentials to get you started 38:06

10M ago38:06

38:06

Interview with Guillaume Desachy and Nicole Krämer Biomarkers help you in all kinds of different ways, so stay tuned while Guillaume, Nicole, and I talk about the following points: What are biomarkers for you? What makes it such an interesting topic? Why do you want to revitalize the biomarker SIG? What are your goals for the SIG? The richness of b…

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Chats with Jenn: Embracing Vulnerability And Leading With Courage 48:52

10M ago48:52

48:52

This is a gem of an episode, jam-packed with insights and tips for everyone, including the following topics: Leading without the job title; how to influence cross-functional teams How he overcame the fear of public speaking How to build and manage a virtual team Creative thinking in an analytical discipline Being comfortable with not being the expe…

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Extrapolation to paedriatics 38:41

10M ago38:41

38:41

Interview with Andrew Thomson Stay tuned while Andrew and I talk about the following: What is extrapolation? What are source and target populations? The guidance states: “Where possible, quantitative methods should be used for the collation of available data and the investigation of potential modifiers of the treatment effect”. How could such quant…

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