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

2© SGS SA 2019 All Rights Reserved

INTRODUCTION: OVERVIEW

n Introduction

n People

n Content

n Timeline

n Evaluation

n Discussion

n Outro

Content

Timeline

People

3© SGS SA 2019 All Rights Reserved

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

4© SGS SA 2019 All Rights Reserved

MANAGER

EXTERNAL

INTERNAL

COACH

COORDINATOR

COLLEAGUES

PEOPLE

n Introduction

n People

n Content

n Timeline

n Evaluation

n Discussion

n Outro

5© SGS SA 2019 All Rights Reserved

CONTENT

Daily work

Background

Practical

n Introduction

n People

n Content

n Timeline

n Evaluation

n Discussion

n Outro

6© SGS SA 2019 All Rights Reserved

CONTENT: BACKGROUND

PhaseDesign

ICH-GCPSOPs

OverallBiometricsStatistics

n Introduction

n People

n Content

n Timeline

n Evaluation

n Discussion

n Outro

7© SGS SA 2019 All Rights Reserved

CONTENT: DAILY WORK

n Introduction

n People

n Content

n Timeline

n Evaluation

n Discussion

n Outro

SASmacro’s

SDTMADaM

SOPsReview

SAP

8© SGS SA 2019 All Rights Reserved

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

9© SGS SA 2019 All Rights Reserved

TIMELINE: BEFORE

n Introduction

n People

n Content

n Timeline

n Evaluation

n Discussion

n Outro

Individual Training Plan

practical

CV BSA

10© SGS SA 2019 All Rights Reserved

TIMELINE: WEEK 1-2

n Introduction

n People

n Content

n Timeline

n Evaluation

n Discussion

n Outro

12© SGS SA 2019 All Rights Reserved

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

13© SGS SA 2019 All Rights Reserved

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

15© SGS SA 2019 All Rights Reserved

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

16© SGS SA 2019 All Rights Reserved

TIMELINE: WEEK 9-10

n Introduction

n People

n Content

n Timeline

n Evaluation

n Discussion

n Outro

Internaldelivery

Feedback

Client delivery

17© SGS SA 2019 All Rights Reserved

>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

18© SGS SA 2019 All Rights Reserved

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

19© SGS SA 2019 All Rights Reserved

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

+

20© SGS SA 2019 All Rights Reserved

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

-

21© SGS SA 2019 All Rights Reserved

clinicalresearch@sgs.com

EUROPE: +32 15 27 32 45AMERICAS: + 1 877 677 2667

www.sgs.com/cro

JOIN US at the SGS BOOTH