ONBOARDING A JUNIOR STATISTICAL PROGRAMMER IN 10 WEEKSMY STORY FROM UNIVERSITY TO FIRST ANALYSIS DELIVERY
Pieter Coppens – Biostatistical Analyst, SGS
Phuse EU Connect 2019 - Amsterdam | 10-13 November 2019
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INTRODUCTION: OVERVIEW
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
Content
Timeline
People
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INTRODUCTION: MY BACKGROUND
n Biomedical engineer
n PhD (engineering education)
n Programming (matlab)
n Research
n Biometrics
n Pharmaceutics
n SAS
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
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MANAGER
EXTERNAL
INTERNAL
COACH
COORDINATOR
COLLEAGUES
PEOPLE
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
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CONTENT
Daily work
Background
Practical
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
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CONTENT: BACKGROUND
PhaseDesign
ICH-GCPSOPs
OverallBiometricsStatistics
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
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CONTENT: DAILY WORK
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
SASmacro’s
SDTMADaM
SOPsReview
SAP
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TIMELINE
C
Befo
re
C C C C C Start day
First delivery
Wee
k 1-
2
Wee
k 3-
4
Wee
k 5-
8
Wee
k 9-
10
Afte
r
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
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TIMELINE: BEFORE
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
Individual Training Plan
practical
CV BSA
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TIMELINE: WEEK 1-2
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
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n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
TIMELINE: WEEK 1-2
SOPDigital QualitySystem H
olid
ay
Prac
tical
itiesSAS
External training
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n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
TIMELINE: WEEK 3-4
SOP Internal training
SDTMADaMmacro
Firs
t pro
ject
protocolSAPCRF
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n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
TIMELINE: WEEK 5-8
Programmingcoach + coordinator
Bio
met
rics
SGS
ICH
-GC
P
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TIMELINE: WEEK 9-10
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
Internaldelivery
Feedback
Client delivery
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>10 weeks
• SAP writing• Metadata• …
Refreshment
• Programming• Regulations• Updates
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
TIMELINE: AFTER
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EVALUATION
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
Week Month
QC FU
Train
Daily
Study
EVALUATION
Day
Continuous & ongoing process
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DISCUSSION
n SGS:§ Meaningful contribution from start§ Other resources remain available§ Less effort during review
n Personal§ Training immediately applied§ Natural structure§ Office-based§ Entire process -> all trainings used
n Client§ Clear communication§ Quality assurance
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
First study
+
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DISCUSSION: DRAWBACKS
n Practical: too late/early
n Information not always used immediately
n Full study:§ Lot of ‘administration’§ Myriad of topics§ Better to focus on one aspect?
n Introduction
n People
n Content
n Timeline
n Evaluation
n Discussion
n Outro
First study
-
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