Join Sam and I while we discuss the processes of determining the right control strategy for a manufacturing process:

• How to determine the control strategy for the manufacturing process?
• How to demonstrate the characteristics of control strategy?
• What is the process flow that works?
• How a complex system work?
• How to understand and optimize control strategy?

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Join us while we talk about this practical guide which has ten effective principles—counterintuitive tactics and strategies—you too can use to become more persuasive in both your professional and personal life:

1. How to become the smartest person in any room
2. How to quickly establish rapport
3. How to create trust with tactical empathy
4. How to generate momentum and make it safe to reveal the real stakes
5. How to gain the permission to persuade
6. How to share what is fair
7. How to calibrate questions to transform conflict into collaboration
8. How to spot liars and ensure follow-through from everyone else
9. How to get your price
10. How to create breakthroughs by revealing the unknown unknowns

Reference: https://www.amazon.de/-/en/Chris-Voss-ebook/dp/B014DUR7L2

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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:

1. Implementer - I do what you tell me
2. Analyser - Tell me what you want to analyse and I will suggest analysis and implement them
3. Consultant - I understand your problem and I advise you what the team should do
4. Leader - I understand your problem and I convince you what we should do
5. Entrepreneur - I deeply understand the business and I foresee the changes in the business. I build an environment in which statistical leaders grow.

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Statisticians support more than just clinical trials in R&D. Some non-clinical areas where statisticians contribute to drug development include:

• Discovery
  • High throughout screening of drug candidates
  • Genomics
• Early Phase
  • Safety studies (animals)
  • Animal models for efficacy
  • In-vitro Analytical methods to predict in-vivo performance
• Mid-late phase
  • Determining manufacturing process targets for clinical trial material (process definition)
  • Determining the best formulation for a drug product
  • Developing robust and accurate analytical methods to assess the quality of the drug substance and drug product
  • Assessing the stability of the drug product
  • Determining the full manufacturing process and the control strategy to ensure high quality (process characterization), including
    • Operating Ranges
    • Determining Critical Process Parameters
    • Developing 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.

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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 quality
    • Understanding 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 Processes
    • Using control charts for on-going monitoring of manufacturing processes
    • Understanding sources of variability that impact the output of the manufacturing process
    • When 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 investigation
    • Building tools to automatically build data sets from manufacturing data and visualize that data
  • Designing new manufacturing processes
    • Applying 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 Services
    • More on this will be covered in a later episode.

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?

• VIS SIG blog
• VIS SIG homepage
• Register for Wonderful Wednesdays
• Grammar of Graphics
• “A Layered Grammar of Graphics” Hadley Wickham. Journal of Computational and Graphical Statistics, Volume 19, Number 1, Pages 3–28 link
• Wonderful Wednesday blog including an upset graph
• Hans Roslings joy of stats

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?

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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?

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Join us while we talk about the following points:

• Different styles of virtual conferences
  • Just recorded sessions 
  • Interactive sessions 
  • Community events
• Get familiar with the software and the app if applicable 
  • Use the chat functionality intentionally
• Know the conference details
  • Who’s attending 
  • Who’s there to talk to 
  • Any profile to set up?
  • Make sure it’s great 
• Taking electronic notes for
  • Post 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

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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 team
• Depth technical training
• Training scheduling
• Fully fledged Statistician or Programmer and permanent employee
• Access to a broad range of additional training that is part of the Veramed Excellence Programme

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