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PharmaSUG proceedings: industry Basics, 72 papers

Pharmaceutical SAS Users Group 2017   May 14-17, 2017 - Baltimore, Maryland

Industry Basics
tweet!  A Practical Guide to Healthcare Data: Tips, traps and techniques
  Greg Nelson, ThotWave
Keywords: healthcare EHR data quality data stewardship patient level data
Pages: 20 Size: 2247 Kb 
Best Paper
tweet!  Good Programming Practices at Every Level
  Maria Dalton, GlaxoSmithKline
Keywords: Good Programming Practices Defensive Programming Quality
Pages: 6 Size: 90 Kb 
tweet!  How to define Treatment Emergent Adverse Event (TEAE) in crossover clinical trials
  Mengya Yin, Ultragenyx Pharmaceutical;; Wen Tan, Ultragenyx Pharmaceutical
Keywords: 'Treatment Emergent Adverse Event' TEAE Crossover 'Washout Periods' 'Severity Change' 'Partial Dates'
Pages: 6 Size: 421 Kb 
tweet!  How to find the best MDR solution for your organization
  Kevin Lee, Clindata Insight
Keywords: MDR CDISC Integration selection SAS
Pages: 3 Size: 242 Kb 
tweet!  SDTM Cartography - Learn To Create SDTM Mapping Specifications
  Donna Sattler, Eli Lilly; Mike Lozano, Eli Lilly and Company
Keywords: Mapping Specification Specs CDISC SDTM Standardization Integration
Pages: 7 Size: 336 Kb 
tweet!  Data Monitoring Committee Report Programming: Considering a Risk-Based Approach to Quality Control
  Amber Randall, Axio Research; Bill Coar, Axio Research
Keywords: Quality control validation DMC Report data monitoring committees
Pages: 9 Size: 333 Kb 
tweet!  Building a Fast Track for CDISC: Practical Ways to Support Consistent, Fast and Efficient SDTM Delivery
  Steve Kirby, Chiltern International Ltd; Mario Widel, Eli Lilly; Richard Addy, Chiltern International Ltd
Pages: 14 Size: 678 Kb 

Pharmaceutical SAS Users Group 2016   May 8-11, 2016 - Denver, Colorado

Industry Basics
tweet!  What makes a “Statistical Programmer” different from a “Programmer”
  Arun Raj Vidhyadharan, inVentiv Health, Somerset, NJ; Sunil Mohan Jairath, inVentiv Health, Somerset, NJ
Pages: 12 Size: 361 Kb 
tweet!  Introduction of Semantic Technology for SAS® programmers
  Kevin Lee, Clindata Insight, Moraga, CA
Pages: 15 Size: 1223 Kb 
tweet!  Programming checks: Reviewing the overall quality of the deliverables without parallel programming
  Shailendra Phadke, Baxalta US Inc., Cambridge, MA; Veronika Csom, Baxalta US Inc., Cambridge, MA
Pages: 8 Size: 170 Kb 
tweet!  Compilation of Errors, Warnings and Notes!
  Anusuiya Ghanghas, Novartis Healthcare Private Limited, Hyderabad, India; Houde Zhang, Novartis Pharmaceuticals, East Hanover, NJ; Rajinder Kumar, Novartis Healthcare Private Limited, Hyderabad, India
Keywords: Errors warnings Notes message syntax compile
Pages: 7 Size: 452 Kb 
tweet!  Practical Implications of Sharing Data: A Primer on Data Privacy, Anonymization, and De-Identification
  Gregory S. Nelson, ThotWave Technologies, Chapel Hill, NC
Pages: 23 Size: 1218 Kb 
tweet!  Good versus Better SDTM: Data Listings
  Mario Widel, Eli Lilly & Co, Indianapolis, IN; Henry Winsor, Relypsa Inc., Redwood City, CA
Keywords: CDISC SDTM ICH E3 Listings
Pages: 11 Size: 512 Kb 
tweet!  Moving from Data Collection to Data Visualization and Analytics: Leveraging CDISC SDTM Standards to Support Data Marts
  Steve Kirby, JD, MS, Chiltern, King of Prussia, PA; Terek Peterson, MBA, Chiltern, King of Prussia, PA
Keywords: CDISC
Pages: 8 Size: 853 Kb 
tweet!  AE: An Essential Part of Safety Summary Table Creation
  Rucha Landge, Inventiv International Pharma Services Pvt. Ltd., Pune, India
Pages: 12 Size: 565 Kb 
Best Paper
tweet!  Handling Interim and Incomplete Data in a Clinical Trials Setting
  Paul Stutzman, Axio Research LLC, Seattle, WA
Keywords: PharmaSUG SAS Interim Incomplete
Pages: 13 Size: 231 Kb 
tweet!  Access OpenFDA: A Cloud Based Big Data Portal Using SAS®
  Jie Roger Zhou, University of Bridgeport, Bridgeport, CT; James Sun, Insmed Inc, Bridgewater, NJ
Pages: 8 Size: 730 Kb 
tweet!  Importance of Niche Provider for Successful NDA Submission: Rescue Case Study
  Aparna Poona, Vita Data Sciences, Waltham, MA; Bhavin Busa, Vita Data Sciences, Waltham, MA; Tim Southwick, Vita Data Sciences, Waltham, MA
Pages: 9 Size: 245 Kb 

Pharmaceutical SAS Users Group 2015   May 17-20, 2015 - Orlando, Florida

Industry Basics
tweet!  The 5 Most Important Clinical SAS? Programming Validation Steps
  Brian C. Shilling, inVentiv Health Clinical, Cape Coral, FL
Pages: 6 Size: 41 Kb 
tweet!  Use of SAS Reports for External Vendor Data Reconciliation
  Soujanya Konda, inVentiv Health Clinical, Hyderabad, India
Pages: 12 Size: 934 Kb 
tweet!  Tackling Clinical Lab Data in Medical Device Environment
  Juan Wu, Medtronic plc., Santa Rosa, CA; Min Lai, Medtronic plc., Santa Rosa, CA
Keywords: Laboratory results Lab test library Lab unit conversion library SDTM LB
Pages: 7 Size: 367 Kb 
tweet!  SAS Grid: Simplified
  Rajinder Kumar, inVentiv International Pharma Services Pvt. Ltd., Pune, Maharashtra (India)
Pages: 6 Size: 182 Kb 
tweet!  Two different use cases to obtain best responses using RECIST 1.1: SDTM and ADaM
  Kevin Lee, Accenture Life Sciences, Berwyn, PA; Vikash Jain, Inventiv Health Clinical, Princeton, NJ
Keywords: CDISC
Pages: 17 Size: 404 Kb 
tweet!  The Disposition Table: Make it Easy
  Endri Endri, ProXpress Clinical Research GmbH, Berlin, Germany; Benedikt Trenggono, ProXpress Clinical Research GmbH, Berlin, Germany
Keywords: Disposition Table SAS Macro Programming Artificial Intelligence
Pages: 10 Size: 331 Kb 
tweet!  Improving Data Quality - Missing Data Can Be Your Friend!
  Julie Chen, United BioSource Corporation, Blue Bell, PA
Pages: 12 Size: 551 Kb 
tweet!  Tips on Creating a Strategy for a CDISC Submission
  Rajkumar Sharma, Nektar Therapeutics, San Francisco, CA
Keywords: CDISC
Pages: 5 Size: 101 Kb 
Best Paper
tweet!  Proc Compare: Wonderful Procedure!
  Anusuiya Ghanghas, inVentiv International Pharma Services Pvt Ltd, Pune, India; Rajinder Kumar, inVentiv International Pharma Services Pvt Ltd, Pune, India
Pages: 12 Size: 311 Kb 

Pharmaceutical SAS Users Group 2014   June 1-4, 2014 - San Diego, California

Industry Basics
Best Paper
tweet!  Challenges in Processing Clinical Lab Data
  Alan Meier, MedImmune, LLC, Gaithersburg, MD
Pages: 15 Size: 651 Kb 
tweet!  TLF Validation Etiquette: What to say, When to Say, How to Say, Why to Say
  Karen Walker, inVentiv Health Clinical, San Diego, CA
Pages: 10 Size: 639 Kb 
tweet!  Common Variables in Adverse Event and Exposure analysis datasets specific for Oncology clinical trials
  Haridasan Namboodiri, PRA International, Horsham, PA
Pages: 11 Size: 222 Kb 
tweet!  Cover the Basics, Tool for structuring data checking with SAS
  Ole Zester, Novo Nordisk, Denmark
Keywords: Datacleaning
Pages: 10 Size: 416 Kb 
tweet!  Attain 100% Confidence in Your 95% Confidence Interval
  Indu Nair, United BioSource Corporation, Blue Bell, PA; Binal Patel, United BioSource Corporation, Blue Bell, PA
Keywords: PROC FREQ 95% Confidence Interval zero frequency binomial proportion difference in proportion Newcombe Method Clopper-Pearson Method Exact Method
Pages: 9 Size: 138 Kb 
tweet!  Good versus Better SDTM – Why “Good Enough” May No Longer Be Good Enough When It Comes to SDTM
  Henry Winsor, Relypsa, Inc., Redwood City, CA
Keywords: CDISC
Pages: 6 Size: 201 Kb 
tweet!  From “Just Shells” to a Detailed Specification Document for Tables, Listings and Figures
  Supriya Dalvi, InVentiv Health Clinical, Mumbai, India
Pages: 13 Size: 750 Kb 
tweet!  Clinical Study Report Review: Statistician’s Approach
  Amita Dalvi, inVentiv Health Clinical, Mumbai, India
Pages: 6 Size: 52 Kb 
Clinical Trial Data Transparency: Seeing is Believing
  Janet Stuelpner, SAS, Cary, NC

Pharmaceutical SAS Users Group 2013   May 12-15, 2013 - Chicago, Illinois

Industry Basics
Best Paper
tweet!  Serving SAS®: A Visual Guide to SAS Servers
  Gregory S. Nelson, ThotWave Technologies, Cary, NC
Pages: 20 Size: 2854 Kb 
tweet!  Analysis of Concomitant Medication Data
  J.J. Hantsch, inVentiv Health Clinical, Chicago, IL; Karl Miller, inVentiv Health Clinical, Lincoln, NE
Pages: 4 Size: 90 Kb 
tweet!  Due (Data) Diligence: Study Data Review for Acquisitions
  Adam Young, ViroPharma Incorporated, Exton, PA; Steve Kirby, ViroPharma Incorporated, Exton, PA
Keywords: Diligence CDISC ADaM SDTM define.xml blankcrf.pdf FDA CDER CBER Submission
Pages: 6 Size: 399 Kb 
tweet!  Map Metadata - Going Beyond the Obvious/Connecting the Dots
  Gregory Steffens, Novartis Pharmaceuticals, East Hanover, NJ; Praveen Garg, ICON Development Solutions, Hanover, MD
Keywords: Map Metadata Greg Steffens Praveen Garg
Pages: 8 Size: 225 Kb 
tweet!  The Value of an Advanced Degree in Statistics as a Clinical Statistical SAS Programmer
  Mark Matthews, inVentiv Health Clinical, Indianapolis, IN; Ying (Evelyn) Guo, PAREXEL International, Waltham, MA
Keywords: Advanced Degree Statistics SAS Career
Pages: 5 Size: 299 Kb 
tweet!  Introduction to the CDISC Standards
  Sandra Minjoe, Accenture Life Sciences, Wayne, PA
Keywords: CDISC FDA data metadata protocol cdash lab sdtm send adam define odm glossary bridg share terminology opencdisc
Pages: 10 Size: 316 Kb 
tweet!  Clinical Trials: If You Can Explain Them to Second Graders, You Can Explain Them to Anyone!
  Lara E.H. Guttadauro, inVentiv Health Clinical, Newport, KY
Pages: 5 Size: 597 Kb 
tweet!  Pretty Please?! Making RTF Output “Pretty” with SAS
  Carol Matthews, United Biosource Corporation, Blue Bell, PA; Elena Kalchenko, United Biosource Corporation, Blue Bell, PA
Pages: 10 Size: 112 Kb 
tweet!  Is Your Data Set Really Validated: Beware of “Blind-Fold” Validation
  Neha Mohan, inVentiv Health Clinical, Mumbai, India; Gayatri Karkera, inVentiv Health Clinical, Mumbai, India
Keywords: Validation
Pages: 4 Size: 48 Kb 
tweet!  SAS® Programmer to Clinical SAS Programmer
  Gayatri Karkera, inVentiv Health Care, Mumbai, India; Neha Mohan, inVentiv Health Care, Mumbai, India
Keywords: SAS Programmer
Pages: 7 Size: 76 Kb 

Pharmaceutical SAS Users Group 2012   May 13-16, 2012 - San Francisco, California

Industry Basics
tweet!  Adapt and Survive: Implementing the new ICH Development Safety Update Report (DSUR)
  Patricia L. Gerend, Genentech Inc., South San Francisco, CA; Rajkumar Sharma, Genentech Inc., South San Francisco, CA
Pages: 10 Size: 76 Kb 
tweet!  Risk Evaluation and Mitigation Strategies (REMS) and How They Impact Biostatistics and Statistical Programming Groups
  Arthur Collins, Biogen Idec, Inc., Cambridge, MA
Pages: 4 Size: 232 Kb 
tweet!  Metadata: Some Fundamental Truths
  Frank DiIorio, CodeCrafters, Inc., Philadelphia, PA
Keywords: metadata metadata cost/benefits metadata design metadata tools metadata implementation
Pages: 10 Size: 82 Kb 
Best Paper
tweet!  Could Have, Would Have, Should Have! Adopting Good Programming Standards, Not Practices, to Survive An Audit.
  Vincent J. Amoruccio, M.A., Alexion Pharmaceuticals, Inc., Cheshire, CT
Keywords: GPP FDA Audit Programming Standards
Pages: 17 Size: 469 Kb 
tweet!  Problem with your SAS® Program? Solutions abound!
  Max Cherny, GlaxoSmithKline, King of Prussia, PA
Keywords: SAS SAS-L SAScommunity.org sas help
Pages: 12 Size: 809 Kb 
tweet!  Using a Picture Format to Create Visit Windows
  Richann Watson, PharmaNet/i3, Batavia, OH
Keywords: picture format visit windows
Pages: 4 Size: 33 Kb 
tweet!  SAS Enterprise Guide Best of Both Worlds – Is it Right for You?
  Sunil K. Gupta, Gupta Programming, Simi Valley, CA
Keywords: SAS Enterprise Guide
Pages: 9 Size: 634 Kb 
tweet!  PROGRAMMER'S SAFETY KIT: Important Points to Remember While Programming or Validating Safety Tables
  Sneha Sarmukadam, Statistical Programmer, PharmaNet/i3, Pune, India; Sandeep Sawant, Manager-Statistical Programming, PharmaNet/i3, Pune, India
Pages: 11 Size: 209 Kb 
tweet!  You Could Be a SAS® Nerd If . . .
  Kirk Paul Lafler, Software Intelligence Corporation, Spring Valley, CA
Keywords: SAS SAS nerd Nerd nerd SAS nerdisms nerdisms Lafler Kirk Lafler Kirk Paul Lafler
Pages: 4 Size: 183 Kb 

Pharmaceutical SAS Users Group 2011   May 8-11, 2011 - Nashville, Tennessee

Industry Basics
tweet!  Success As a Pharmaceutical Statistical Programmer
  Sandra Minjoe, Octagon Research; Mario Widel, Roche Molecular Systems
Keywords: skills acquired inherent analytical success
Pages: 7 Size: 200 Kb 
tweet!  Oncology Trials 101 - The Basics and Then Some
  Dave Polus, COMSYS Clinical, Portage, MI
Pages: 4 Size: 75 Kb 
tweet!  Brave New World: How to Adapt to the CDISC Statistical Computing Environment
  Jeff Abolafia, Rho, Inc., Chapel Hill NC; Frank DiIorio, CodeCrafters, Inc., Philadelphia PA
Keywords: CDISC ADaM SDTM DASH ADaM model SDTM model metadata workflow standards standards implementation statistical computing
Pages: 11 Size: 259 Kb 
Best Paper
tweet!  Similarities and Differences in SAS Programming Among CRO and Pharmaceutical Industries
  Sandra Minjoe, Octagon Research Solutions, Wayne, PA; Mark Matthews, i3Statprobe, Indianapolis, IN
Keywords: career track opportunities variety CRO Biotech Pharmaceutical
Pages: 6 Size: 44 Kb 
tweet!  Your Dataset Looks Fine – But Does It Comply with '99?
  Meenal Sinha, Octagon Research Solutions, Inc., Wayne, PA
Keywords: Compliance Programming Best Practice Data Quality
Pages: 3 Size: 73 Kb 
tweet!  Using Six Sigma Methodologies to Find a Solution for Increasing Training Completions
  Eunice Ndungu, Merck, North Wales PA; Shazia Khawaja, Merck, North Wales PA; Janet Low, Merck, North Wales PA; Steve Miola, Merck, North Wales PA
Pages: 22 Size: 548 Kb 

Pharmaceutical SAS Users Group 2010   May 23-26, 2010 - Orlando, Florida

Industry Basics
tweet!  Medical Device and Diagnostic Industry 101
  Carey Smoak, Roche Molecular Systems, Inc.
Keywords: Device Diagnostic Approval CDISC
Pages: 5 Size: 32 Kb 
tweet!  GCP 101 OR “Why we do What we do the Way we do it”
  Elaine Dempsey, Parexel International
Keywords: GCP WHO ICH Good Clinical Practices Nuremburg
Pages: 7 Size: 62 Kb 
tweet!  Pressures on SAS programming roles and their evolution in the competitive global environment
  Vijay Moolaveesala, i3statprobe;Mark Matthews, i3statprobe
Keywords: Role Evolution Competitive global environment
Pages: 3 Size: 41 Kb 
Best Paper
tweet!  Don't run away, it's only Labs
  Lucy Wang, United Biosource Corp.;Paul Slagle, United Biosource Corp.
Keywords: introduction basics labs laboratory normals conversion headaches standards standardization CTC grading
Pages: 4 Size: 39 Kb 
tweet!  Clinical Programming For Novice
  Ramesh Ayyappath, Merck & Co, Kenilworth, NJ
Keywords: Clinical Programming Beginner Documents Dictionary
Pages: 5 Size: 40 Kb 
tweet!  Surviving Survival Analysis: Basic Knowledge from a Programmer's Viewpoint
  Deb Cassidy, PPD
Keywords: Survival analysis PROC LIFETEST
Pages: 9 Size: 97 Kb 
Best Paper
tweet!  Macros Are Helpful - Tips to Avoid Giving Them a Bad Rep
  Deb Cassidy, PPD
Keywords: macros efficiency
Pages: 7 Size: 64 Kb 
tweet!  The Compliance and Implementation of Clinical Outcome Disclosure on ClinicalTrials.gov
  Eric Sun, sanofi-aventis Pharmaceuticals;Craig Anderson, sanofi-aventis Pharmaceuticals
Keywords: ClinicalTrials.gov XML PRS FDAAA
Pages: 13 Size: 1133 Kb 
tweet!  Programming Validation: Perspectives and Strategies
  Parag Shiralkar, Eliassen Group
Keywords: ÿþ Programming Validation strategies
Pages: 4 Size: 39 Kb 
tweet!  Evolving role of statistical SAS® programmers in the pharmaceutical industry
  Venkata Bhamidipati, Merck & Co;Haiping Zhou, Merck & Co
Keywords: Evolving SAS Statistical Porgrammes
Pages: 5 Size: 48 Kb 
tweet!  SAS Programmer's check list-Quick checks to be done before the statistical reports go off the SAS Programmer's table
  Thomas Joseph, Independent Consultant;Babru Hottengada, Meridian Information System
Keywords: SAS/STAT check list
Pages: 7 Size: 324 Kb 
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