Biostatistics/Data Management

Providing a forum for information and discussion about current and evolving issues in these disciplines as well as training on basic topics

Leadership

CO-CHAIRS
Jon Haddad, Synta Pharmaceuticals Corporation
Cindy Steinberg, BioBridges LLC

Steering Committee
Jennifer Angell, Associate Director, Biostatistics, Genzyme Corporation
Jameelah Aziz, Manager Clinical Data Management, Cubist Pharmaceuticals
Michelle Harrison, Manager, Clinical Data Management, Coley Pharmaceuticals Group
Kay Larholt, Vice President and Executive Director, Biometrics, Abt Associates
Scott Moseley, Director, Biometrics, Vertex Pharmaceuticals

Mission

Our Mission is to provide a sustainable non-commercial forum for information, discussion and the exchange of ideas about Biostatistics and Data Management (BDM) for the MBC membership. Topics will include current and evolving issues in these disciplines as well as address membership needs for training on basic topics. The BDM Committee will disseminate information through workshops and presentations by leveraging the direct experience of industry experts and the MBC membership.

Action Plan

The BDM Committee will utilize its steering committee to develop and organize an annual plan of meetings to be held each month. Topics and formats will be consistent with the BDM committee’s mission, continuing a tradition of promoting new ideas and finding new ways to look at Biostatistics and Data Management in the clinical trials process.  In addition, we will participate in joint functions with other MBC committees to bring expertise from different perspectives of clinical development such as Technology and Regulatory Compliance as they relate to the overall success of managing a clinical trial.

The BDM Committee will develop a mechanism for succession planning and continuity, and will establish guidelines for steering committee participation.

Meetings

Date Event
4/10/08 Clinical Statistics for Non-Statisticians -- REGISTRATION CLOSED
5/16/08 Confronting Common Challenges in Managing Laboratory Data
6/10/08 Data Integrity - The role and impact of Quality Assurance Compliance and Validation
7/11/08 Consolidating Data - Data Migration, Warehousing and Business Intelligence
3/12/08 CDISC Implementation Strategies: Lessons Learned and Future Directions
1/23/08 Computer Systems Validation in the 21st Century
12/12/07 EDC Comes of Age: Surviving the Transition from Paper-Based Data Capture to EDC
11/13/07 Behind the Scenes at the FDA: Revelations of a Former Statistical Reviewer -- MBC Biostatistics & Data Management Committee
10/30/07 Data Monitoring Committees: Key Considerations for Biometric Professionals -- MBC Biostatistics & Data Management Committee
10/3/07 Clinical Trials Simulation: A Statistical Approach -- Biostatistics and Data Management Committee
8/22/07 A Case Study of a Mid-Size Pharmaceutical Company's Biostatistics and Data Management Group with NDA Submissions: Past, Recent and Future-- Biostatistics and Data Management Committee
7/18/07 CDISC 101 -- Biostatistics and Data Management Committee
6/14/07 PK for the Rest of Us -- Biostatistics and Data Management Committee
5/17/07 Your Biostatistician is your friend - Really! --Biostatistics and Data Management Committee
4/13/07 Adaptive Trial Design -- MBC Biostatistics and Data Management Committee
3/29/07 Outsourcing Strategy for Biostatistics and Data Management -- MBC Biostatistics and Data Management Committee Meeting

Past Presentations

Date Presentation
7/11/08 Consolidating Data - Data Migration, Warehousing and Business Intelligence - Postle
7/11/08 Consolidating Data - Data Migration, Warehousing and Business Intelligence - Perry
6/10/08 Data Integrity - The role and impact of Quality Assurance Compliance and Validation- Malia
6/10/08 Data Integrity - The role and impact of Quality Assurance Compliance and Validation- Del Paggio
5/16/08 Confronting Common Challenges in Managing Laboratory Data- Callen & Donovan
5/16/08 Confronting Common Challenges in Managing Laboratory Data- Sadhwani
4/10/08 Clilnical Statistics for Non-Statisticians- Larholt
3/12/08 CDISC Implementation Strategies: Lessons Learned and Future Directions-Vertex
3/12/08 CDISC Implementation Strategies: Lessons Learned and Future Directions -Introduction
3/12/08 CDISC Implementation Strategies: Lessons Learned and Future Directions-Genzyme
3/12/08 CDISC Implementation Strategies: Lessons Learned and Future Directions-Octogon
12/7/07 EDC comes of age -surviving the transition from paper-based to EDC studies- Ancukiewicz
12/7/07 EDC comes of age -surviving the transition from paper-based to EDC studies- Aalyson
12/7/07 EDC comes of age -surviving the transition from paper-based to EDC studies- Surensky
10/30/07 Data Monitoring Committees: Key Considerations for Biometric Professionals- Lavin
10/30/07 Data Monitoring Committees: Key Considerations for Biometric Professionals- Haddad

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