1. Flyer Agenda Stats Leaders 2024 final
2. Meeting Agenda EFSPI Stat Leaders 2024 final

3. Intro slides final
4. Breakout Groups
5. Session 1 SurveyResults
6. EFSPI Session 1 – Breakout summary
7. Session1 Summary
8. Session 2_StatsLeaders_Methods_Leaders_role plays
9. EFSPI Session 2 – Breakout summary
10. Session 2 Summary
11. Session 3_DEI _INTRO
12. EFSPI Session 3 – Breakout summary
13. Session 3 Summary
14. EFSPI Stat Leaders 2024 overall summary

1. Agenda EFSPI Stat Leaders 2023 final
EFSPI pre meeting survey results

Day One
3a. Ice-breaker Session Games
3b.Ice-breaker Session_Answers
4a. Session 1 Introduction – Role in Strategic Decision Making 2023_05_22
4b. Session 1 Steve Ruberg – Leadership and Quantitative Decision-making
4c. Session 1 Survey Results
4d-1. Session 1 Early Careerist Evanthia Koukouli
4d-2. Session 1 Early Careerist Arina Kazimianec
4d-3. Session 1 Early Careerist Jenny Wissmar
4e. Session 1 Summary

Day Two
5a. Session 2 Introduction – Data Sharing and Collaboration with academia
5b. Session 2 Martin Posch – Clinical Trial Data Sharing Uses and Challenges in Implementation
5c. Session 2 Mimmi Sundler Rebecca Sudlow – Maximising the value of clinical trial data A decade o. Session 2 Mimmi Sundler Rebecca Sudlow – Maximising the value of clinical trial data A decade
5d Session 2 Summary
6a Session 3 Introduction survey results – Leadership Management and Future Direction of Statistics
6b. Session 3 summary

7. Summary of 2023 EFSPI Statistics Leaders Meeting final

1. Agenda EFSPI Stat Leaders 2022 with pre-read (002)

Day One
2. Day1_session1_Erik Pulkstenis_Biometrics Statistics Leaders Consortium
3. Day1_session1_Silvia Garcia_EFPIA
4. Day1_session1_Breakout_Summary_Networking and collaborations
5. Day1_Keynote_Stanley Shaw_Perspectives on Innovative Data Science Leadership in the Life Science.
Day1_Keynote_Stanley Shaw_Perspectives on Innovative Data Science Leadership in the Life Science

Day Two
6. Day2_session2_Next generation statisticians
8. Day2_session3_Keynote_Chris Holmes_Biostatistics into the future

Summary 12th EFSPI Stat Leaders Meeting

Day One
1 A 12th EFSPI Stat Leaders Meeting Day 1
1 B EFSPI intro on leadership skills
1 C EFSPI Leadership skills development for biostatisticians Lundbeck
1 E EFSPI Leadership – Career Development – Andy Grieve
1 F 12th EFSPI Stat Leaders Meeting Day 1 – break-out session
2 A Perspectives on use of clinical data in the regulatory review process and scientific advice by regulatory authorities
2 B EFSPI Statistical Leaders – Raw Data submission – EMA

Day Two
Session 3 A 12th EFSPI Stat Leaders Meeting Day 2
Session 3 B The RSS Data Science Section – EFSPI
Session 3 C EFSPI DS 2021 v4
Session 4 A Ways of working survey results EFSPI Statistics Leaders meeting 2021
Session 4 B 12th EFSPI Stat Leaders Meeting Day 2 – Material for break-out session on Flexible Workplace

Video Feedback
Stefan Driessen
Andreas Jens Otto
Emmanuel Zuber
Armin Schueler
Olavi Kilkku
Justine Rochon
Chrissie Fletcher

01_EFSPI 2020_Opening
02_EFSPI 2020_01_SafetyAnalyses_ImpulsePresentation (002)
02_EFSPI 2020_02_SafetyAnalyses_Regulatory
02_EFSPI 2020_03_SafetyAnalyses_Industry
02_EFSPI 2020_04_SafetyAnalyses_Academia
02_EFSPI 2020_05_SafetyAnalyses_MentiResults
03_EFSPI 2020_01_OrganisationalEvolution_SurveyResults
03_EFSPI 2020_02_OrganisationalEvolution_MentiResults
04_EFSPI 2020_Updates
05_EFSPI 2020_Topics2021
06_EFSPI 2020_Feedback
07_EFSPI 2020_Summary

01_Opening
02_Reflections on 10-years of EFSPI Statistics Leaders Meetings
03_How to be an Effective Statistician
04_Agile Experience Tour Introduction
05_Design Thinking EFSPI Website
06_Making Statisticians Bold and Entrepreneurial
07_1_Preparation_RoundTableDiscussion_Skill Sets
07_2_Preparation_RoundTableDiscussion_Statistics and Data Science
07_3_Preparation_RoundTableDiscussion_Statisticians in drug discovery and early stages
07_4_Preparation_RoundTableDiscussion_Masking in open label studies_not discussed
07_5_Preparation_RoundTableDiscussion_Use of external controls in regulatory decision making
08_Call for Topics EFSPI Statistics Leaders Meeting 2020
09_Announcement EFSPI Regulatory Workshop 2019
10_Summary 10th EFSPI Statistics Leaders Meeting_July 2019

Summary of the 2018 Meeting from the July 2018
01_EFSPI_StatsLeaders_2018_Opening
02_EFSPI_StatsLeaders_2018_Training
03_EFSPI_StatsLeaders_2018_Welcome_BayesianStatistics
04_EFSPI_StatsLeaders_2018_SIGs
05_EFSPI_StatsLeaders_2018_QDM SIG
06_EFSPI_StatsLeaders_2018_WS_HistoricalControls
06_EFSPI_StatsLeaders_2018_WS_PragmaticTrials
06_EFSPI_StatsLeaders_2018_WS_StoryMapping

1 Opening and Updates
2 Decision Making
3 Collaboration with Academia
4. AbbVie_A CLOSER LOOK_CorpOverview_101216
5 Patented Trial Design
6 Data Science
7 EFSPI Priorities
EFSPI Stats Leaders Meeting 2017 – Flyer
Summary Stats Leaders Mtg 2017

1 Opening Stats Leaders Mtg 2016
2 Regulatory Interactions
3 SIG Small Populations
4 SIG Modelling_Simulation
5. PrecisionMedicine
6 SIG AIMS
8 Summary Statistics Leaders Meeting 2016 for EFSPI website
EFSPI flyer Stats Leaders Mtg 2016

1. Stefan William Chrissie Opening Stats Leaders Mtg 2015
2. Chrissie Fletcher Statisticians adding value to HTA final
3. Uli Burger Stats leadership on datasharing Brussels v0 02
4. Christoph Gerlinger EFSPI leaders – regulatory interaction 2015-07-01
5. Egbert Biesheuvel SIG Rare Diseases EFSPI_SIG_StatsLeader2015
5. Stefan SIG Update 2015
6. Armin Schueler Real World Evidence_EFSPI_2015-07-01_Final
6th Stats Leaders Report
7. Alexander Schacht benefit-risk_SIG_update_Brussels_final2015_06_30
8. Chrissie Fletcher EFSPI Statistics Leaders 2015 estimands
9. Stefan Stats Leaders Mtg 2016
EFSPI flyer Stats Leaders Mtg 2015

1opening
2clinicaltrialdatasharing
3sigupdate
4sigintegrateddataanalysis
5sigpharmacoepidemiology
6recentdevelopmentsandsurvey
2014efspistatisticalleadersmeetingfinalminutes

1welcome
2specialinterestgroups
3medicaldevices
4benefitrisksig
5ematransparency
6emaclinicaltrialcg
7datagskclinicaltrials
8datatransparencyrsuburger
9alternativeviewsdatatransparencyuliburger
10breakoutgroupsalternatives
012013efspistatisticalleadersmeetingminutesfinal2

1.__efspi_statistical_leaders_mtg_agenda
2.__opening_remarks
3.__benefit_risk
4.__adaptive_statisticians_and_challenges_beyond_clinical_trials
5.__sigs_update
6.__career_paths_for_statisticians_in_pharmaceutical_industry
statsleadersjune2012mins
strategy_outcome
strategy_setup

1.__efspi_statistical_leaders_meeting_june_2011_agenda
2.__statistical_leaders_efspi_presentation_june_2011_fa
3.__efspi_model_based_drug_development
4.__slides_nmastleader_20110607
5.__efspi_hta_update
6.__efpsi_risk_benefit__topic_update_june_2011
7.__efsi_accreditation
8.__efspi_career_paths_june_2011
9.__efspi_totality_of_evidence

1.__agenda
2.__introduction
3.__professional_development_for_statisticians
4.__assessment_of_risk_benefit
5.__health_technology_assessment
6._minutes