CMC Statistics Community

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  • 1.  Stat Snax Update

    Community Leadership
    Posted 02-26-2024 17:30

    Hi All, 

    As the community starts to prepare for the launch of Stat Snax Video Set 2, the leadership team is collecting ideas for video set 3! For those new to the community Stat Snax are short videos (5-10 minutes) on key statistical concepts teaching non statisticians. The list below outlines the Videos record in sets 1 and 2 and provide a current list of topics for future videos.   

    Video set 1: Stat Snax - YouTube

    1. What is a P-Value?
    2. What is a confidence Interval?
    3. R^2 and R^2 Adjusted
    4. Statistical Significance vs Practical Importance
    5. What's the difference between an Equivalence Test and a Difference Test?
    6. Statistical Process Control vs Statistical Quality Control
    7. Interpreting Stability Regression per ICH Q1E
    8. Fitting a Model to Stability Data

    Soon to be released Video Set 2

    1. Scientific Method
    2. Statistical Thinking
    3. Good Graphical Practices
    4. Determining Sample Size
    5. Transformation of Data
    6. Evaluation of Outliers
    7. Non-inferiority testing of standard deviations

    Potential Ideas for Video Set 3

    • Fixed vs Random lot models for stability data
    • D vs I optimal designs
    • Retests in case of OOS (n new observations & reportable value)
    • Goodness of Model Fit / Model Assumptions
    • Using Quality Ranges in a Comparability Study
    • High Level description of Bayesian Statistics

    All ideas are welcome! Once a list of ideas has been established, the leadership team will ask for volunteers to prepare presentations and record the videos. Suggesting an idea, does not put you on the hook for creating a video. Please add to either the discussion board or the Excel sheet sent by Aili. 



    ------------------------------
    Jonathan Ross
    Director MSAT and CMC Statistics
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------


  • 2.  RE: Stat Snax Update

    Community Leadership
    Posted 03-05-2024 12:16

    All Stat Snax Videos and Files can also be found in the Stat Snax Folder in the CMC Statistics Library. 



    ------------------------------
    Jonathan Ross
    Director MSAT and CMC Statistics
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------



  • 3.  RE: Stat Snax Update

    Community Leadership
    Posted 03-14-2024 16:50

    Three new ideas have been proposed for video set 3: 

    1. Monte Carlo Simulation
    2. Selecting the right control chart
    3. Data Management/Cleaning

    There is still time to submit ideas. Please submit your ideas by replying to the discussion post, editing the Excel Sheet on the Teams site, or by bringing up the topic at the CMC Statistics Meeting on March 20th. 

    Remember, submitting a topic does not mean you are required to prepare the slides and create the video. The leadership team will ask for presenters once the topics have been selected. 



    ------------------------------
    Jonathan Ross
    Director MSAT and CMC Statistics
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------



  • 4.  RE: Stat Snax Update

    Community Leadership
    Posted 03-18-2024 15:55

    Another potential topic was submitted for video set 3: What is a tolerance interval?

    There is still time to submit ideas. Please submit your ideas by replying to the discussion post, editing the Excel Sheet on the Teams site, or by bringing up the topic at the CMC Statistics Meeting on March 20th. 

    Remember, submitting a topic does not mean you are required to prepare the slides and create the video. The leadership team will ask for presenters once the topics have been selected. 

     



    ------------------------------
    Jonathan Ross
    Director MSAT and CMC Statistics
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------



  • 5.  RE: Stat Snax Update

    Community Leadership
    Posted 03-25-2024 14:56

    Hi All, 

    Volunteers are needed to help create and record the Stat Snax. Please reply to this thread if you are interested in volunteering. Here are the topics still needing presenters: 

    1. D vs I optimal Designs
    2. Monte Carlo Simulations
    3. Data Management/Cleaning
    4. What is a Tolerance Interval? 

    All volunteers need to be identified by April 5th. This would then allow sufficient time to submit the AAPS webinar form, create and review presentations, and record the Stat Snax to be ready for release by October 20th at PharmSci360. 

    Video Set 1 had great viewership and was one of the most viewed AAPS series in 2022. You're hard work on these does not go unnoticed!



    ------------------------------
    Jonathan Ross
    Director MSAT and CMC Statistics
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------



  • 6.  RE: Stat Snax Update

    Community Leadership
    Posted 04-01-2024 17:30

    Hi All, 

    Thank you to those who have volunteered. We still need volunteers for: 

    1. Monte Carlo Simulation
    2. Data Management/Cleaning

    Please reach out if you are interested. 



    ------------------------------
    Jonathan Ross
    Director MSAT and CMC Statistics
    Rezolute Bio
    Bothell WA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------