The Effective Statistician - in association with PSI

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 development, medical affairs, digital health applications, study program simulation, influencing skills, and data visualization. For more information or to register for the conference visit: theeffectivestatistician.com To learn more about the conference, CLICK HERE. If you want to sponsor the conference, CLICK HERE for the details.

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 National Institute for Health and Care Excellence and Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E9 (R1) Addendum. Value in Health. S1098-3015(22)02148-9. doi: 10.1016/j.jval.2022.08.008.

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 potential risks associated with a drug or vaccine. In the near future, more companies will adopt a systematic approach to aggregate safety assessment planning and IND safety reporting. This process will develop a better understanding of the safety profile of drugs and ensure that patients' safety is well-thought-of.

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!

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 your friends and colleagues who might learn from it. Happy Holidays!

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 manufacturing and how looking at data from all stages of production helped identify where the problem was occurring so it could be fixed Do not underestimate the leadership skill set statisticians have - you may be able to influence and lead projects more than you think!

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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 statistician be more detailed in checking the data and using such advantage to offer a more effective solution to existing issues. There is a need to start up early in determining the problem and communicating it with others. For a person to take the first mover advantage, there is a need to speak out. It takes courage to do so, but with the right confidence and the right motivation, reaching out to the audience is easier and more effective for statisticians to consider. Listen to this episode, you would be able to get the best value you can apply in your own profession as a statistician and as a leader in the industry.

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 not fit within the common ground variable in a multi-country study. It is expected that the lessons presented in this episode will help statisticians pay more serious attention to the differences in their base sample source to reduce the margin of mistakes once the data is already being analyzed. Listen to this episode now to see how this information could personally and professionally help your journey in statistics.

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 leadership from time to time Own the mistakes of the team Do not micromanage Motivate others to be leaders too Giving your full trust to your team plays a big role to their success and more.... Links and references: The Seven Habits of Highly Effective People - Stephen R Covey Trust and Inspire - Stephen M.R. Covey Start with Why - Simon Sinek Leadership Strategy and Tactics - Jocko Willink The Trusted Executive - Dr John Blakey Podcast Episode: Lifting The Lid - The one with the internal coach from the pharma industry Here is a link to Aluns other podcast appearance talking about his journey as a coach (Link).