practice makes perfect

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Practice Makes Perfect: Training and Performing in the Pharmaceutical Industry

Sunil Gupta

Quintiles

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Each employee faces challenges and obstacles along their pharmaceutical career paths.

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Practice Makes Perfect

What is unique about the pharmaceutical industry?

Pharmaceutical Industry

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Practice Makes Perfect

Developing an effective training program

Pharmaceutical Industry Training

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Practice Makes Perfect

Performing in the pharmaceutical industry

Pharmaceutical Industry Training Performing

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What is unique about the pharmaceutical industry?

Clients/Partners

Products/Services

Employees/Managers

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Clients working together as CRO Partners

Four C’s in CRO business

CRO team members

Key Performance Indicators (KPI)

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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

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CRO team members are seamlessly integrated with the client

Client Statistical Programmers

Insource Extension of Client: CRO Programming Staff

CRO Management

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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

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Products and services helping to reach drug sales goals

21 CFR Part 11 requirement

Standard macros

QC and delivery

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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

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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

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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

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Employees and managers sharing a common vision

Communication, Communication, Communication

‘Sharpen the Saw’

Industry-Related Magazines

One-on-one meetings

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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

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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

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Stay Current with Industry-RelatedMagazines (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

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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

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Practice Makes Perfect

Developing an effective training program

Pharmaceutical Industry Training

“Behavioral change is required for learning”

- David Garvin, Harvard Business Review 1993

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Developing an effective training program

Client Requirements

Best Practices

Corporate Ladder

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Training Program meets client’s requirements

Client working environment

Real-world programming tasks

Monitor, evaluate and provide feedback

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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

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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

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Monitor, evaluate and provide feedback

Entry Junior Senior/Manager

Detail feedback and close monitoring

Daily or every other day

Mentor by Senior/Manager

General feedback and monthly monitoring

One-to-one meetings

Mentor by Senior/Manager

Minimum feedback and yearly monitoring

Performance reviews

Mentor by Director

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Best Practices training program

Continuous Improvement

Train Feedback

Update

“Plan, Do, Check, Act”, Deming

Mastery of

SAS Programming

Understanding of Clinical Trials Data

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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

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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

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Climbing the corporate ladder

Entry (< 2 yrs)

Junior (2 – 5 yrs)

Senior/ Manager

(>= 5 yrs)

Responsibilities

Training

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Titles and general responsibilities need to be understood and applied

Entry Junior Senior/Manager

Statistical Programmer I

Statistical Programmer II

Lead Programmer

- Validation Programming of simple listings- Edit Checks- Simple Data Listings

- Source Programming- Annotated Graphs- Macro Validation Programming- Opportunity for leadership roles

- Critical Thinker- Efficacy Programming- Maintain Program Index excel file- Tools/Macro Development- Effective Delegator

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Training program needs to match expected deliverables by position

Five Moments of Need1. 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 WrongMosher, Bob, “Informal Learning: Are We Missing a HUGE Opportunity?,” ASTD 2008, research by Dr. Conrad Gottfredson

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Practice Makes Perfect

Performing in the pharmaceutical industry

Pharmaceutical Industry Training Performing

“Teaching the employee to perform effectively” - Bob Mosher, Learning Guide Solutions 2008

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Performing in the pharmaceutical industry

Poor and

Good

Performance

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Red flags of poor performance

Screen candidates for skills

SAS programming skills need improvement

Communication of clinical issues is poor

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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

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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)

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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

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Critical success factors of good performance

Highly Motivated Employees

Searches to understand the ‘why’

Becomes more productive with experience

Follows trends for increased productivity

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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?

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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

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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?

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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

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In summary, challenges in the pharmaceutical industry can be overcome

Effective Communication

Early identification of Safety Issues

Understanding Clinical Data

Following FDA Requirements

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Through effective partnership, training and commitment, you are better prepared for the next level.

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Practice Makes Perfect: Training and Performing in the

Pharmaceutical Industry

Sunil GuptaSunil.Gupta@Quintiles.com

Quintiles