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Practice Makes Perfect: Training and Performing in the Pharmaceutical Industry Sunil Gupta Quintiles

Each employee faces challenges and obstacles along their pharmaceutical career paths. http://www.freeimages.co.uk/

Practice Makes Perfect What is unique about the pharmaceutical industry? Pharmaceutical Industry

Practice Makes Perfect Developing an effective training program Pharmaceutical Industry Training

Practice Makes Perfect Performing in the pharmaceutical industry Pharmaceutical Industry Training Performing

What is unique about the pharmaceutical industry? Clients/Partners Products/Services Employees/Managers

Clients working together as CRO Partners Four C’s in CRO business CRO team members Key Performance Indicators (KPI)

Knowing the Four C’s in CRO business apability (Experience/Expertise) ompatibility (Process/Staff) apacity (Resources/Schedule) ost (Comprehensive/Reasonable) Vogel, J.R., "A Practical Approach to Achieving Success with CROs" http://www.jrvogel.com/training.html C

CRO team members are seamlessly integrated with the client Client Statistical Programmers Insource Extension of Client: CRO Programming Staff CRO Management

Key Performance Indicators (KPI) are important to monitor improvements Quantify and track: Quality meets expectation Timeliness of deliverables Communications of specifications and issues Individually and combined Deliverables: analysis data sets, tables, lists and graphs

Products and services helping to reach drug sales goals 21 CFR Part 11 requirement Standard macros QC and delivery

Following the 21 CFR Part 11 rule is a requirement “ Who did what to which data/program, why, when and how?” Audit Trail LMS, e-learning, Training records CDISC (New) Code of Federal Regulations , http:// www.fda.gov/oc/gcp / , http://www.21cfrpart11.com/pages/faq/index.htm

Standard macros help to automate common tasks Consistent Titles Footnotes with date and program name Page Margins Treatment group columns Descriptive Statistics Number of significant digits in p-values

QC and delivery expectations should be met Standard tables Standard lists Analysis data sets Custom tables Custom lists Custom graphs On Schedule 10 to 15 simple tables/day Expect Delays 1 complex table /2 – 3 days

Employees and managers sharing a common vision Communication, Communication, Communication ‘ Sharpen the Saw’ Industry-Related Magazines One-on-one meetings

Communication, Communication, Communication Frequent, Focused, Future-oriented, Flexible Document details of each task Take minutes of each meeting Early and often More important than ever when considering global teams Meet As Needed E-mail, IM Frequently Phone Often

Everyone should take time to ‘Sharpen the Saw’ Monthly training sessions help to reinforce updated processes Self-guided review of SAS papers and management guides for personal and technical growth Review of selected SAS books from department library - Sharpening Your SAS Skills Quick Results with the Output Delivery System The Complete Guide to the Macro Language and Proc Report

Stay Current with Industry-Related Magazines (Articles by Sunil Gupta) Practice Makes Perfect: Making the Most of training for Statistical Programmers, ECP Magazine, Spring 2008 Know Your Industry: Developers in Health Care, Certification Magazine, July 2006 Applications Developers: The Artists of Technology, Certification Magazine, March 2006 Must-Have Tools for Developers, Certification Magazine, January 2006 On-the-Job Training Improves Job Performance, Certification Magazine, May 2005

One-on-one meetings at least once a month Ideally face to face Confirm understanding, expectations, and priorities Measure progress towards meeting goals Provide feedback from client

Practice Makes Perfect Developing an effective training program Pharmaceutical Industry Training “ Behavioral change is required for learning” - David Garvin, Harvard Business Review 1993

Developing an effective training program Client Requirements Best Practices Corporate Ladder

Training Program meets client’s requirements Client working environment Real-world programming tasks Monitor, evaluate and provide feedback

Simulate client working environment to prevent surprises Client access set-up instructions Training program consistent with client’s SOPs Enhance client’s standard macro user guides Client project file paths

Assign real-world programming tasks using client tools Create data edit checks Create analysis data sets Create tables and lists Create rtf files using ODS Validate analysis data sets, tables, lists and graphs Client Legacy Clinical Study

Monitor, evaluate and provide feedback Minimum feedback and yearly monitoring Performance reviews Mentor by Director General feedback and monthly monitoring One-to-one meetings Mentor by Senior/Manager Detail feedback and close monitoring Daily or every other day Mentor by Senior/Manager Senior/Manager Junior Entry

Best Practices training program Continuous Improvement Train Feedback Update “ Plan, Do, Check, Act” , Deming Mastery of SAS Programming Understanding of Clinical Trials Data

Mastery of SAS Programming is essential Apply advanced techniques and macros to create reports and graphs Effective debugging and validation methods Effective testing and documentation methods

Understanding of Clinical Trials Data is important Address complex clinical data issues Apply correctly primary and secondary endpoints Understand drug development process Look for information on SAS Clinical Trials for Statistical Programming Certification exam at PharmaSUG 2009

Climbing the corporate ladder Entry (< 2 yrs) Junior (2 – 5 yrs) Senior/ Manager (>= 5 yrs) Responsibilities Training

Titles and general responsibilities need to be understood and applied - Critical Thinker - Efficacy Programming - Maintain Program Index excel file - Tools/Macro Development - Effective Delegator - Source Programming - Annotated Graphs - Macro Validation Programming - Opportunity for leadership roles - Validation Programming of simple listings - Edit Checks - Simple Data Listings Lead Programmer Statistical Programmer II Statistical Programmer I Senior/Manager Junior Entry

Titles and general responsibilities need to be understood and applied - Critical Thinker - Efficacy Programming - Maintain Program Index excel file - Tools/Macro Development - Effective Delegator - Source Programming - Annotated Graphs - Macro Validation Programming - Opportunity for leadership roles - Validation Programming of simple listing - Edit Checks - Simple Data Listings Lead Programmer Statistical Programmer II Statistical Programmer I Senior/Manager Junior Entry

Training program needs to match expected deliverables by position Five Moments of Need 1. When Learning for the First Time 2. When Wanting to Learn More 3. When Trying to Remember and/or Apply 4. When Things Change 5. When Something Goes Wrong Mosher, Bob, “Informal Learning: Are We Missing a HUGE Opportunity?,” ASTD 2008, research by Dr. Conrad Gottfredson

Practice Makes Perfect Performing in the pharmaceutical industry Pharmaceutical Industry Training Performing “ Teaching the employee to perform effectively” - Bob Mosher, Learning Guide Solutions 2008

Performing in the pharmaceutical industry Poor and Good Performance

Red flags of poor performance Screen candidates for skills SAS programming skills need improvement Communication of clinical issues is poor

Screen candidates for relevant skills Technical skills – Practical Questions Can the candidate get the job DONE? Clinical Trials Experience – Task Walk Through Does the candidate KNOW the Job? Communication skills – Proactive? Can the candidate INTERACT on the job? Teamwork/Department Procedures – Follow SOPs? Ask interview team members to rate each candidate

SAS programming skills need improvement SAS Procedures: Proc Freq, Proc Report, Proc Tabulate, Proc Compare, Proc Transpose, Proc SQL ODS, Macros and Data Step Programming Validation and Debugging Techniques SQL Data Dictionary tables Graphs Documentation Unix (dependent on client)

Communication of clinical issues is poor Clinical data issues affect everyone Quicker resolution by programming or specification update Engagement builds trust and relationship Biostatisticians Clinical Data Management Data Issue Statistical Programming

Critical success factors of good performance Highly Motivated Employees Searches to understand the ‘why’ Becomes more productive with experience Follows trends for increased productivity

Highly motivated to learn multiple ways for complete programming task Managing Time and Priorities/Planning & Organizing Learning/Initiative – Enjoy training process Interest/Sports/Hobbies – Do you have other strengths OUTSIDE of the job?

Searches to understand the ‘why’ behind SOPs and SDLC Flexibility/Adapts well to changes – Follows detail instructions Leadership/Integrity - Why were you hired? Knowing ’clinical data structure and content’ Knowing ‘why’ SDLC is important

Becomes more productive with experience Thinking Critically – Can you EXPAND the job? Independent Programmer - SAS Programming Certification - SAS Clinical Trials Statistical Programming Self-motivator - Proactive to volunteer for more projects?

Applies trends for increased productivity Expect More Tasks completed in same time Intelligent questions to improve process Automation of standard and simple tasks Expect Less Time to resolve analytical issues Time to resolve programming bugs Feedback and monitoring of deliverables M O R E L E S S

In summary, challenges in the pharmaceutical industry can be overcome Effective Communication Early identification of Safety Issues Understanding Clinical Data Following FDA Requirements

Through effective partnership, training and commitment, you are better prepared for the next level. http://www.freeimages.co.uk/

Practice Makes Perfect: Training and Performing in the Pharmaceutical Industry Sunil Gupta [email_address] Quintiles

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