Conference 2013

PHUSE 2013 was the ninth PHUSE Annual Conference and was held at the Radisson Blu Royal Hotel in Brussels 13th to 16th October and was chaired by Sascha Ahrweiler (UCB BioSciences GmbH).
Best in Stream Winners are highlighted in bold text.

2013 Papers / Presentations

Applications and Software Development

WINNER AD01: A Guide to Deploying Subversion for Version Control of SAS Programs in the Pharmaceutical Industry
Tim Williams, UCB BioSciences GmBH
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AD02: QlikView
Anthony Caudard, Sanofi
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AD03: The Dynamic Cube Viewer-OLAP Made Easy
Raymond Ebben, OCS Consulting
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AD04: Statistical Programming Outsourcing KPI Dashboard - A Tool for Better Collaboration
Quian Wang & Thierry Paquet, Merck Sharp & Dohme (Europe) Inc
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AD05: Organising Deliverables for Clinical Trials - The Concept of Analyses and its Implementation in EXACT
Hansjorg Frenzel, PRA International
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AD06: CARE to CRaM
Greg Fuller, Independent
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AD07: EDC Integration
Rob Jongen, CSL Behring GmbH
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AD08: Clinical Reporting Summary
Ian Fleming & Chris Olinger, d-Wise Technologies Inc
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Coders Corner

CC02: How Do You Use Look-up Tables?
Philip Holland, Holland Numerics Ltd
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CC03: How to Add TortoiseSVN-Functionality to SAS Enhanced Editor
Oiver Wirtz, UCB BioSciences GmbH
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CC04: Your SAS Secrets Exposed!
David Weiner, Quanticate
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CC05: What's in it? SAS Arrays to Check Efficiently for Emptiness of Variables and Datasets
Guillaume Godin, Business & Decision Life Sciences
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CC06: Dynamic SAS Programming with XML Templates
Bart Van Win, Business & Decision Life Sciences
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CC07: Are We Really Doing Independent Validation of Statistician Procedures in SAS?
Sameer Bamnote, Cytel
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WINNER CC08: Macro to Conduct Consistency Checks
Johanna Gaignard & Walter H. Hufford, Novartis
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CDISC and Industry Standards

CD01: Interpreting CDISC ADaM IG Through Users Interpretation
Angelo Tinazzi, Cytel
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WINNER CD02: ADaM Standards - Organising the Unorganised
Heike Reichert, Bayer Pharma AG
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CD03: Round Trip Ticket -Using the Define.xml file to Send and Receive your Study Specifications
Julie Maddox, SAS Institute
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CD04: HL7 RIM - An Introduction for Non-Technical Professionals
Joerg Dillert, Oracle
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CD05: Define-XML v2 - What's New
Lex Jansen, SAS Institute
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CD06: Standards Governance - A First Insight
Claudia Meurer, Merck Serono
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CD07: Standard Protocols Using Guided Navigation
Michaela Jahn, F. Hoffman-La Roche
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CD08: ADaM Datasets - Standard and Submission Ready
Karin Fleischer Steffensen, Ferring Pharmarceuticals
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CD09: Interpretation of the Output from the OpenCDISC Checker
Joergen Iversen, LEO Pharma A/S
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CD10: The Evolution of SDTM- What's New
Tina Apers, Business & Decision Life Sciences
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CD11: Considerations in the Submission of Holter (EG) Data in an SDTM Compliant Format
Elsa Lozachmeur, Sophie Arnould & Joseph Rowley, Novartis
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CD12: The Missing Link: Results Level Metadata
Jeff Abolafia, Rho
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CD13: SDTM Oncology Domains: From Patient to Data to Narrative
Kennenth Stolzfus, Accenture
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CD14: Is your Library a Success: Manage & Measure Conformance Across Partners and Projects
Lauren Shinaberry & Bart Van Win, Business & Decision Life Sciences
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Coding Solutions

WINNER CS01:Get The Most out of Your Data by the Power of R Graphics
Peter Bewerunge, HMS Analytical Software
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CS02: The Great Outdoors - (Using SAS External File and SAS File 1/0 Functions)
Lawrence Heaton-Wright, Quintiles
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CS03: A SAS Macro to Generate High Quality Enhanced Kaplan-Meier Plots Using Graphic Template Language
Konrad Zywno, i3 Pharmaceutical Services (Deutschland) GmbH & Bartosz Kutyla, SAS Institute
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CS04: Array Today - Utilising the Power of Multi-Dimensional Array
Elas Lozachmeur & Joseph Rowley, Novartis
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CS05: Creating define.xml from a SAS Program
Joergen Iversen, LEO Pharma A/S
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CS06: Coding Solutions for Resampling Methods with SAS
Volker Harm & Richardus Vonk, Bayer Pharma AG
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CS07: Crafting Clinical Reports with Stone-Age Tools
David Garbutt, Garbuttconsult & Magnus Mengelbier, Limelogic
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Data Handling

DH01: Drug Groupings and Workflow Options for the Processing and Review of Concomitant Medication Data
Heiko Baermann, Bayer Pharma AG
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DH02: Importing OpenClinical Data in SAS: It's Possible! - Our Experiences
Jules van der Zalm, OCS Consulting
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WINNER DH03: Semantic Technology and CDISC Standards
Frederik Malfait, IMOS Consulting & Scott Bahlavooni, Genentech
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DH04: Overcoming Difficulties in Implementing RECIST Criteria
Gerlind Ruhnke, Merck KGaA
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DH05: Going Against the Flow: Backmapping SDTM Data
Pantaleo Nacci, Novartis
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DH06: Standardising the Standards - The Benefits of Consistency
Nathan James, Roche
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DH07: Elephants and Storms - Using Big Data Techniques for Analysis of Large and Changing Datasets
Geoff Low, Medidata Solutions
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DH08: Taming Rave: How to Control Data Collection Standards?
Dimitri Kutsenko, Entimo AG
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DH09: Datacut Strategies: What, Why & How
Hiren Naygandhi, Roche
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DH10: Time Travel for Librarians: Versioning Complex Library Metadata for Past, Present or Future Retrieval
Nico De Leeuw & Ine Felsenstein, Business & Decision Life Sciences
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Health Outcomes and Epidemilogy

HE01: My Big Data Experience - Getting my Feet Wet in the PUddle and Still Treading Water 2 Years Later
Robert Walls, Roche
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HE02: Economic Evaluation in Clinical Trials. You Can Do it with SAS
Artur Usov, OCS Consulting
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HE03: Anatomy of an Epidemiology Study
Paul Murray, FTP Software Consultants
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HE04: Cross-sectional and Episodic Deduplication in Record Linkage
Rients van Wijngaarden, PHARMO Institute
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HE05: The AZ_PLM Nausea Study: A Novel Patient-Centric Collaboration
James Weatherall, AstraZeneca & Paul Wicks, PatientsLikeMe
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WINNER HE06: Around the World in Three Statistical Models: Determing the Level of Measurement Invariance Across Countries of a PRO Instrument
Dirk Heerwegh, Business & Decision Life Sciences
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Industry Starters

IS01: Efficacy Endpoints in Oncology
Angelo Tinazzi, Cytel
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IS02:Useful Principles and Practices for Professional SAS Programmers
Patrick Warnat, HMS Analytical Software
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IS03: An Introduction to SDTM - Part II
Jennie McGuirk, ICON PLC
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IS04: Thorough QTc Studies: Patients at Heart...
Marc Derycke & Jeans-Otto Andreas, UCB BioSciences GmbH
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IS05: Statistics: The Fourth Dimension of a "Statistical Programmer"
Gauri Khatu & Vibhavari Inamadar, Cytel
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IS06: Oncology Endpoints: An Unexpected Journey
Waseem Jugon & Mijanur Rahman, Roche
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Management (No Presentations/Papers available)

MA01:The Changing Landscape of our Industry
Christian Mueller, F. Hoffman La Roche (Basel, CH)

MA02: Crisis Management - How Would You Respond?
Edward Glynn, Ernst & Young LLP

MA03: The Vendor Selection Policy and it's Implications
Matt Jones, Veramed Limited

MA04: Clinical SAS Programming in India: Need vs Want
Simon Wilcock, ICON PLC

MA05: Risk-Based Monitoring - Why Does it Matter to Programmers?
Shafi Chowdhury, Shafi Consultancy Limited

MA06: A Perspective on Data Transparency - The Journey so Far and Where's Next?
Katherine Macey, Roche

Professional Development & Training

PD01: Pain of Your Back(up) or Efficient Resourcing of Back-up Solutions for Programming Leads
Adam Amborski,  UCB BioSciences GmbH

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PD02: One Vision, Many Interpretations?
Todd Case, Biogen Idec
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PD03: Hey You! Or to Whom it May Concern
Kathryn Wright, Cmed
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WINNER PD04: Making of a Project Manager
Manjusha Gode, Cytel
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PD05: Are You out of Your Mind? CDISC Mappings Using the Mind Map Tool
Niels Both & Johannes Ulander, S-Cubed
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PD06: Leading a Team When you are Note the Subject Matter Expert
Vijay Reddi, Roche
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Poster Presentation

PP01: SASUnit: General Overview and Recent Developments
Patrick Warnat & Peter Bewerunge, HMS Analytical Software GmbH
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PP02: Bringing Skeletons out of the Closet
Parag Naithani, Ferring Pharmaceuticals
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PP03: Reporting on Oracle Clinical by JReview
Fleury Randrianarivo, Sanofi
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PP04: Descriptive Summary Tables Made Easy
Shafi Chowdhury, Mohammad Siddick & Rafi Rahi, Shafi Consultancy Limited
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PP05: Help your Fellow Colleagues: Customised SAS Graphs Could Provide Peek into Subject's Progress
Arun Lal & Jari Ahvenainen, Grunenthal GmbH
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PP06: Two-way Ticket, Please...All aboard the SAS® Clinical Standards Toolkit 1.5 Express
Lex Jansen, SAS Institute
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PP07: Complex Randomisations Need Not Be Complex
Fiona Brock, Quanticate
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PP08: Two into One
Kathryn Wright, Cmed Clinical Services
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PP09: ProjectTrackItL Automate your Project using SAS
Abhishek Bakshi, Cytel
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PP10:Quick Checks for Quick Review
Gauri Khatu, Cytel
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PP11: Standards for the Management of Clinical Trial Data, Why are they Needed, What is Needed?
Isabelle Abousahl, Ipsen Innovation
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PP12: Check your Standards - An Example
Véronique Bourcier, Bayer Vital GmbH
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PP13: Maintaining Consistency Between a Substance Database and Single Study Databases
Dieter Hartz, Boehringer Ingelheim
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PP14: Pharmacokinetics Standardisation: Patients' Healthcare is Becoming Central
Francois Vandenhende
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PP15: Supporting End to End Standards in Study Setup
Anna Louise Wilson, F. Hoffman-La Roche
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WINNER PP16: What I Know is
Nicolas Guerro, Novartis
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PP17: Report Inspector
Vibhavari Inamdar, Cytel
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PP19: Call for Scripts and Get Involved with FDA/PHUSE Scripts Repository
Lina Ulkjaer Jorensen, Novo Nordisk
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PP20: Overview of Receiver Operating Characteristic (ROC) Curves in SAS PROC LOGISTIC
Fiona Brock, Quanticate
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PP21: Using the SAS Intelligence Platform for Clinical Trials Programming
Melissa Martinez, SAS Institute

PP22: Annotate CRFs and Keep Track of Them
Rohit Bamga, Biometrical Practice BIOP AG
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PP23: Proc Import Diagnostic Macro
Shan Lee, GlaxoSmithKline
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PP24: Mission Possible: Your Assisgnment is to Validate Output for a Study
Susan Fehre, BioClin Inc & Kevin Coulson, Emporia State Univesity
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Regulatory

RG01: Orphan Indication Therapies: Programming for a Patient Population without Options
Todd Case, Biogen Idec
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RG02: CDISC Journey on Solid Tumor Studies using RECIST 1.1
Kevin Lee, Cytel
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WINNER RG03: Evolving Regulatory Guidance on the Submission of Standardised Data
James Johnson, Summit Analytical LLC
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RG04: On the Submission's Road with CDISC ADaM
Romain Jegou, Business & Decision Life Sciences
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Software Demonstrations

SD01: SAS Predictive and Visual Analytics: Software Demonstration
Andy Bayliss, SAS Institute
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SD02: eBESTreports - The Fastest Way to Conclusions
Tuomas Kemppainen & Juha Hyssala, StatFinn
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SD03: EXACT - A Metadata Driven System for Creating Standard Mockups and Data Displays
Kent Letourneau, PRA International
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SD04: An Integrated Platform for Standards Management and Study Conduct - Managing Efficiently your Standards
Ine Felsenstein, Business & Decision Life Sciences, Jasmine Kestemont & Stijn Rogiers, Johnson & Johnson
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SD05: Data Validations, Getting Full Control Over your Data Standards Compliance and Data Flow
Sébastien Roland, Business & Decision Life Sciences
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SD06: Spotfire for Statisticians and Statistical Programmers
Alistair Dootson, Dootsonic Ltd & Mark Demesmaeker, TIBCO
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SD07:What's New in SAS 9.4
Daniel Christen, SAS Institute
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SD08: Utilising Data Warehousing to Validate Clinical Trial Projects and to Select and Recruit Patients
Tim Armitage, Oracle
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Statistics and Pharmacokinetics

SP01: Posch-Bauer Seamless Test with SAS
Antonio Nieto & Javier Gómez, PharmaMar
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SP02: Bayesian Statistics: Concept and Bayesian Capabilities in SAS
Mark Janssens, I-BioStat, Hasselt University
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SP03:Using PROC GENMOD to Analyses Ratio to Placebo in Change of Dactylitis
Imgard Hollweck, UCB BioSciences GbmH
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SP04: Multivariate Bioequivalence
Shital Agawane & Sanjukta Roy, Cytel
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SP05: Computation of Cls for Binomial Proportions in SAS and its Practical Difficulties
Jose Abraham, Kreara Solutions Pvt Ltd
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SP06: Computing the 'Competing Risks' - Modeling Survival Data with Competing Risk Events using SAS® Macros
Swapna Deshpande, Cytel
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WINNER SP07: Extensions of Cox Model for Non-Proportional Hazards Purpose
Jadwiga Borucka, Parexel
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SP08: Determination of Body Sway area by Fourier Analysis of its Contour
Thomas Wollseifen, i3 Pharmaceutical Services GmbH
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SP09:Lexis Expansion - Age-at-Risk Adjustment for Survival Analysis
Lai San Hong, Redsen Ltd & Sarah Lewington, Clinical Trial Service Unit and Epidemiological Studies Unit of the University of Oxford
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SP10: Central Statistical Monitoring in Action
Francois Torche & Erik Doffagne, CluePoints
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Technical Solutions

TS01: Visual Approaches for Safety Analysis and Review of Clinical Trials
Valerie Nedbal, SAS Institute
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TS02: Designing ADaM Datasets: KISS the Complexity Goodbye
Bill Gibson, SAS Institute
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WINNER TS03: A How-To Guide for Extending Controlled Terminology Using SAS Clinical Data Integration
Melissa Martinez, SAS Institute
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TS04: Generic Functions in R Illustrated by Examples for the Survival Package
Martin Gregory, Merck Serono
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TS05: Using a Clinical Data Review Tool in an SAS based Environment
Michael Hersch, Bayer Healthcare
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TS06: Developing an Integrated Platform, Getting the Best out of Several Technologies
Jean-Marc Ferran, Qualiance, Bart van Win & Sebastian Roland, Business & Decision Life Sciences
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TS07: Clinical Dashboards - Optimising the Reviewing Process!
Rahul Paul Choudhury, Cytel
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TS08: Moving to SAS Drug Development 4
Magnus Mengelbier, Limelogic
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TS09: Patient Cloud and the Future of Clinical Trials
Christopher Temme, Medidata Solutions
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University Day

UD01: Improving Medical Research and Related Healthcare through Standardisation
Jennie McGuirk, ICON PLC
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UD02: What Makes Oncology Special?
Johanna Mursic, Novartis
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UD03: What Makes a 'Good Program'?
Dean Grundy, Roche Products Ltd
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UD04: Reflections on a Career Pharmaceutical Statistical Sciences: My Journey
James Johnson, Summit Analytical LLC
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UD05: Statistical Programming for Dummies
Sven Greiner & Nicola Tambascia, Accovion GmbH
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