The Effective Statistician - in association with PSI

Leadership is multidimensional. It depends on lots of different skills like communication, being a good team player, building trust and relationship, negotiating conflicts, and more. The kind of leadership that I am talking about is not supervising other people or the administrative type of leadership, but it's a type of cross functional influencing where you lead others that don't necessarily report to you.To simplify it, we have developed these 5 levels of statistical leadership: Implementer - I do what you tell meAnalyser - Tell me what you want to analyse and I will suggest analysis and implement themConsultant - I understand your problem and I advise you what the team should doLeader - I understand your problem and I convince you what we should doEntrepreneur - I deeply understand the business and I foresee the changes in the business. I build an environment in which statistical leaders grow. Listen to this insightful episode and share this with your friends and colleagues who might learn from it!

Interview with Sam Gardner Statisticians support more than just clinical trials in R&D. Some non-clinical areas where statisticians contribute to drug development include: DiscoveryHigh throughout screening of drug candidatesGenomicsEarly PhaseSafety studies (animals)Animal models for efficacyIn-vitro Analytical methods to predict in-vivo performanceMid-late phaseDetermining manufacturing process targets for clinical trial material (process definition)Determining the best formulation for a drug productDeveloping robust and accurate analytical methods to assess the quality of the drug substance and drug productAssessing the stability of the drug productDetermining the full manufacturing process and the control strategy to ensure high quality (process characterization), includingOperating RangesDetermining Critical Process ParametersDeveloping quality specifications for inputs (drug substance, raw materials) and outputs (drug product specifications) There are other areas that statisticians can contribute in non-clinical R&D.... basically anywhere you need to generate and evaluate data in R&D, you can find an application of statistics. Listen to this episode and share this with your friends and colleageus!

Interview with Sam Gardner What is non-clinical pharmaceutical statistics?Join us while I talk about this topic with Sam and dive deeper into these points: Non-clinical statistics is the application of statistics in pharmaceutical R&D and manufacturing and that is not directly related to planning and analyzing clinical trials.There are numerous statistical issues to deal with in these areas, and often regulatory expectations require the use of statistical methods.In this episode we discussed example areas for Non-Clinical Statistics in the Manufacturing and Quality area (also known as Chemistry, Manufacturing and Controls (CM&C))Analytical Methods for assessing qualityUnderstanding the science and technology is important (understanding how the data is actually generated or "how data happens").Determining appropriate specifications for a drug product and ensuring that the natural variation in the measurements will not lead to failing specifications. Qualifying and determining the defined content of chemical reference standards (using appropriate experimental designs)Ongoing Manufacturing ProcessesUsing control charts for on-going monitoring of manufacturing processesUnderstanding sources of variability that impact the output of the manufacturing processWhen something goes wrong: for example there is a bad batch that fails to meet its quality specification, and when this happen, an investigation has to be conducted, and statistical thinking, data gathering and combining, data visualization, data mining and experimental design can be used as part of the investigationBuilding tools to automatically build data sets from manufacturing data and visualize that dataDesigning new manufacturing processesApplying the principles of good process design. Highly recommend book for any statistician: Juran on Quality by Design: The New Steps for Planning Quality into Goods and ServicesMore on this will be covered in a later episode.

Interview with Steve Mallett and Bodo Kirsch The Wonderful Wednesday Webinar series was introduced in an earlier episode. In this episode we dive deep into what has happened over 1 year of the Wonderful Wednesday Webinars. This great series on visual analytics helped us to learn how we can use visualizations of data in our development process and beyond. Bodo as the new chair and Steve as an early member are talking with me about this initiative of the EFSPI/PSI Visualisation special interest group. Join us while we discuss the following points: What have you learned about data visualization in the last year from the WWW?What was your favorite visualization and why?What makes this webinar series special for you?What would you recommend to someone wanting to take part? References VIS SIG blogVIS SIG homepageRegister for Wonderful WednesdaysGrammar of Graphics“A Layered Grammar of Graphics” Hadley Wickham. Journal of Computational and Graphical Statistics, Volume 19, Number 1, Pages 3–28 linkWonderful Wednesday blog including an upset graphHans Roslings joy of stats

Interview with Sam Gardner Let's welcome Sam Gardner as our new co-host for our podcast show! In his first episode as a co-host, we spend some time getting to know more about him while he answers the questions below: How did he learn about this podcast and get connected to it?Why is he on the podcast & what are his plans for future collaboration?What is your educational background?Where has he worked, what kind of work has he done in the past?What is he currently doing now?Outside work, what does he like to do? Listen to this episode and share this with your friends and colleagues!

Interview with Dooti Roy Join Dooti and I while we discuss the surprising opportunities of smartphone apps in clinical studies and discuss the following questions How do you see the role of smartphone apps in clinical studies developing?What additional features become possible with such applications?Where does this impact studies?How will this change the way we analyse studies? Listen to this episode now and share this with your friends and colleagues!

Join us while we talk about the following points: Different styles of virtual conferencesJust recorded sessions Interactive sessions Community eventsGet familiar with the software and the app if applicable Use the chat functionality intentionallyKnow the conference detailsWho’s attending Who’s there to talk to Any profile to set up?Make sure it’s great Taking electronic notes forPost beyond the conference on social media Share learnings with your colleagues Praise your favourite speakers on social media and share your key take away and include an open question to trigger further discussions Listen to this episode and share this with your colleagues!

Interview with Diana, Nick, and Rhys Listen to this episode while we dive deep into these advantages of joining this program: Transition from graduate to effective member of a clinical biostatistics teamDepth technical trainingTraining schedulingFully fledged Statistician or Programmer and permanent employeeAccess to a broad range of additional training that is part of the Veramed Excellence Programme Listen to this episode and share it with others!

Interview with Dooti and Qiqi Join us and learn more while we talk about the following points: Why have you started the BI Conn statistics academy?Who is the target audience for this academy?How has the academy evolved over time?What are your plans for 2021? Reference: Summer Academy website: https://events.stat.uconn.edu/BI-UConn/ Short video on academy: https://www.linkedin.com/posts/dootiroy_uconnsummeracademy2020-activity-6704186061901357056-PTL3

Listen to this episode while I discuss the following important points: Believe in yourselfYour experienceYour educationYour intent to move the project/the company forwardDo you need to state these to build trust?What is the problem?Tell a storyEvoke emotionsReference to the webinar about presentation skillsWhat’s in it for your business partner?Timelines?Budget?Recognition?Can you quantify it?Give a rangeA guestimate is better than nothingThink about possible objectionsAddress them upfrontAgain understand your audienceShow that you careProvide a call to actionWhat do you want them to do?What do they need to decide? Listen to this episode and share this with your friends and colleagues!