Download - Practice Makes Perfect
![Page 1: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/1.jpg)
1
Practice Makes Perfect: Training and Performing in the Pharmaceutical Industry
Sunil Gupta
Quintiles
![Page 2: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/2.jpg)
2
Each employee faces challenges and obstacles along their pharmaceutical career paths.
http://www.freeimages.co.uk/
![Page 3: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/3.jpg)
3
Practice Makes Perfect
What is unique about the pharmaceutical industry?
Pharmaceutical Industry
![Page 4: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/4.jpg)
4
Practice Makes Perfect
Developing an effective training program
Pharmaceutical Industry Training
![Page 5: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/5.jpg)
5
Practice Makes Perfect
Performing in the pharmaceutical industry
Pharmaceutical Industry Training Performing
![Page 6: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/6.jpg)
6
What is unique about the pharmaceutical industry?
Clients/Partners
Products/Services
Employees/Managers
![Page 7: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/7.jpg)
7
Clients working together as CRO Partners
Four C’s in CRO business
CRO team members
Key Performance Indicators (KPI)
![Page 8: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/8.jpg)
8
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
![Page 9: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/9.jpg)
9
CRO team members are seamlessly integrated with the client
Client Statistical Programmers
Insource Extension of Client: CRO Programming Staff
CRO Management
![Page 10: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/10.jpg)
10
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
![Page 11: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/11.jpg)
11
Products and services helping to reach drug sales goals
21 CFR Part 11 requirement
Standard macros
QC and delivery
![Page 12: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/12.jpg)
12
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
![Page 13: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/13.jpg)
13
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
![Page 14: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/14.jpg)
14
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
![Page 15: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/15.jpg)
15
Employees and managers sharing a common vision
Communication, Communication, Communication
‘Sharpen the Saw’
Industry-Related Magazines
One-on-one meetings
![Page 16: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/16.jpg)
16
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
![Page 17: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/17.jpg)
17
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
![Page 18: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/18.jpg)
18
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
![Page 19: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/19.jpg)
19
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
![Page 20: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/20.jpg)
20
Practice Makes Perfect
Developing an effective training program
Pharmaceutical Industry Training
“Behavioral change is required for learning”
- David Garvin, Harvard Business Review 1993
![Page 21: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/21.jpg)
21
Developing an effective training program
Client Requirements
Best Practices
Corporate Ladder
![Page 22: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/22.jpg)
22
Training Program meets client’s requirements
Client working environment
Real-world programming tasks
Monitor, evaluate and provide feedback
![Page 23: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/23.jpg)
23
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
![Page 24: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/24.jpg)
24
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
![Page 25: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/25.jpg)
25
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
![Page 26: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/26.jpg)
27
Best Practices training program
Continuous Improvement
Train Feedback
Update
“Plan, Do, Check, Act”, Deming
Mastery of
SAS Programming
Understanding of Clinical Trials Data
![Page 27: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/27.jpg)
28
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
![Page 28: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/28.jpg)
29
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
![Page 29: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/29.jpg)
30
Climbing the corporate ladder
Entry (< 2 yrs)
Junior (2 – 5 yrs)
Senior/ Manager
(>= 5 yrs)
Responsibilities
Training
![Page 30: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/30.jpg)
31
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
![Page 31: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/31.jpg)
33
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
![Page 32: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/32.jpg)
34
Practice Makes Perfect
Performing in the pharmaceutical industry
Pharmaceutical Industry Training Performing
“Teaching the employee to perform effectively” - Bob Mosher, Learning Guide Solutions 2008
![Page 33: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/33.jpg)
35
Performing in the pharmaceutical industry
Poor and
Good
Performance
![Page 34: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/34.jpg)
36
Red flags of poor performance
Screen candidates for skills
SAS programming skills need improvement
Communication of clinical issues is poor
![Page 35: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/35.jpg)
37
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
![Page 36: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/36.jpg)
38
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)
![Page 37: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/37.jpg)
39
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
![Page 38: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/38.jpg)
40
Critical success factors of good performance
Highly Motivated Employees
Searches to understand the ‘why’
Becomes more productive with experience
Follows trends for increased productivity
![Page 39: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/39.jpg)
41
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?
![Page 40: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/40.jpg)
42
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
![Page 41: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/41.jpg)
43
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?
![Page 42: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/42.jpg)
44
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
![Page 43: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/43.jpg)
45
In summary, challenges in the pharmaceutical industry can be overcome
Effective Communication
Early identification of Safety Issues
Understanding Clinical Data
Following FDA Requirements
![Page 44: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/44.jpg)
46
Through effective partnership, training and commitment, you are better prepared for the next level.
http://www.freeimages.co.uk/
![Page 45: Practice Makes Perfect](https://reader035.vdocuments.us/reader035/viewer/2022062220/557ad23bd8b42add288b4ed3/html5/thumbnails/45.jpg)
Practice Makes Perfect: Training and Performing in the
Pharmaceutical Industry
Sunil [email protected]
Quintiles