In modernen globalen Pharmaunternehmen wird es für Nicht-Statistiker immer wichtiger, den Wert und die Anwendung von Statistiken zu verstehen, um den Wert der Daten zu maximieren. Dieser Kurs richtet sich an Fachleute, die in der pharmazeutischen Industrie arbeiten und keine oder nur geringe Vorkenntnisse in Statistik haben, da wir gleich zu Beginn mit den Grundlagen beginnen.
Der Schwerpunkt liegt nicht auf der Software, sondern auf dem Verständnis der grundlegenden statistischen Konzepte, der Interpretation der Ergebnisse und der Erörterung der Frage, wie das Wissen angewandt und effizient in die Arbeitsabläufe integriert werden kann.

Who Should Attend

The course is aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians or Professionals working in the Pharmaceutical Industry who wish to gain basic knowledge of the subject.

Course Objectives

In diesem grundlegenden, aber weitreichenden Kurs werden Techniken zur Durchführung grundlegender statistischer Verfahren an Datensätzen behandelt, die für die Pharmaindustrie typisch sind. Es gibt viele grundlegende Konzepte, die verstanden werden müssen, bevor die Statistik ihr volles Potenzial nutzen kann, um nützliche und informative Antworten zu geben. Der Kurs stellt sicher, dass diese Konzepte auf nicht-technische Weise verstanden und dann anhand von Datenbeispielen demonstriert werden.

Mathematical details are kept to a necessary minimum and the focus is on interpretation of statistical output and illustrate applications with data from dummy clinical trials or published data. The objective of the course is not to teach how to become a statistician, but to help to work with statisticians, ask them the right questions and get the maximum value when reviewing statistical output.

The basics of statistics are presented to give background and a common base to start from and the applications and use of statistics in drug development is then discussed. The role of the statistician and their ability to help with decision making is also explained.

The following Key Topics will be addressed:

Module 1 – The Basics: 10th November – 14:00-17:00 CET (incl. 30 mins break)

• Descriptive Statistics (Summary Measures of Location and Spread)
• Describing Variation (Standard Deviation & Standard Error)
• Presenting Results (p-values & Confidence Intervals)
• Visualisations for presentation and explanation
• Power and Sample Size (incl. Type I and Type II Error)

Module 2 – Design Issues: 12th November – 14:00-17:00 CET (incl. 30 mins break)

• Endpoints and Estimands
• Populations
• Avoiding Bias
• Crossovers vs Parallel Gp
• Equivalence & Non-Inferiority
• Multiplicity

Course Leader

Gemma Hodgson, MSc, CStat. has worked in the Pharmaceutical Industry for over 20 years. Gemma began her career at Pfizer working in global teams on major phase III projects. After 13 years at Pfizer working in phase I through to phase IV, Gemma moved to Takeda R&D in London, focusing on close liaison with other departments within the organisation. Since 2012 Gemma has worked for and now runs Qi Statistics Ltd. Gemma has considerable experience in rolling out statistical training programmes to non-statisticians in a variety of industries.

Learning Methodology

Es werden viele praktische Beispiele gegeben und der Schwerpunkt liegt auf der Anwendung und dem Verständnis und nicht auf den Gleichungen und dem technischen Hintergrund. Die Schulung ist so weit wie möglich interaktiv und wird informelle Übungen (mit Antworten!) und Diskussionen umfassen.

Technical Requirements

The training modules will be delivered via digital platform. In order get access you will need an internet connection, audio (from computer speakers or microphone), and a webcam (standalone or integrated with your monitor/laptop).

Continuing Education

This course is accredited by the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM).

Registration Fee

CHF 680.00 + 7.7% VAT
15 % reduction for SwAPP and SBA members
Special fees for CTC employees
Special rates available for PhD Students, please contact training@ctcresourcing.de

Registration fees include: Course documentation and a course participation certificate.
Payment: After registration you will receive confirmation and an invoice with instructions on how to complete the bank transfer. Full prepayment is needed prior to the course.

Cancellation Policy

• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund
In case of no show, no refund will be made

Document

ClinStats_pgm flyer.pdf

If you have NOT received an official confirmation 7 days after registering, please call CTC at +41 61 695 88 66 or send an email to info@ctcresourcing.de.

THANK YOU!