and the importance of stakeholder-relationships our mindset, … · we drive and continuously...
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Statistical Programming in the Future – Our Mindset, Data F.A.I.R.ness, and the Importance of Stakeholder-Relationships*
PhUSE EU Connect Amsterdam 10-13NOV2019Dipl. Dok. Christoph Ziegler – F. Hoffmann - La Roche, Basel, Switzerland
*among many other aspects
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The Futuristic Agenda
• The Theme – Background and Context
• Soft-Skills vs. Technical Skills
• The Statistical Programming Mindset
• Data F.A.I.R.ness
• Stakeholder Relationships
• Conclusions
• Q&A
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The Theme – Background and Context
20xx
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The Theme – Background and Context
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Doing now what patients need nextwhat does Statistical Programming need to do now?why is speed, agility and change needed?→ Understanding the Data, Decision Making, Outputs
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The Theme – Background and Context
Time - Statistical Programming Evolution
Technical Up-skilling
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Soft-Skills vs. Technical Skills
We cannot only look at technical up-skilling (although important!)…………7
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Statistical Programming Evolution
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The Context
Statistical Programming
Different Roles
Mindset
StakeholdersTechnical Upskilling
Standard Reporting Centers
External Business Partners
New Processes and ToolsTrainings
Changing Teams
Disease Molecule
KnowledgeData
F.A.I.R.ness
Project Management
Filing / Reporting
Speed
Working Groups
Recruiting Onboarding
Time for Programming?
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The Statistical Programming Mindset - Future
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The Statistical Programming Mindset - Future• Passion & Commitment• Curiosity / Learning (on-time!)• Fixed vs. Growth Mindset• Challenge the Status Quo• Taking Risks• Understand the Landscape we are in• Agility & Planning (vs. emergency)• Speed• Be smart• Pro-activity (with stakeholders!)• Be Empowered• Value Generation• Flexibility• Data Citizens (F.A.I.R.)• Critical Thinking• Being an Equal Partner• Automation (we are not there yet!)• Analytical Strategy• ---> Engage with Stakeholders
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The Statistical Programming Mindset - Future
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The Statistical Programming Mindset - Future
• Our Behaviors are key to enable Agility and to drive Change
– Inclusive & Pleasing → Trusting Others to take the right Decision(s)– Conservative → Courageous– Perfectionism → Pragmatic and intuitive– Rewarding Performers → Rewarding Collaborators and fast Decision Makers
• We have to embrace ambiguity and feel comfortable with “failing forward “
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Data F.A.I.R.ness
● Sharing of Data ● Personalized Medicine by meaningful Data Insights
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Data F.A.I.R.ness - What can Statistical Programmers do?
● Planning○ Data Standards, Terminology○ Vendor, Requirements○ Metadata
● Acquisition○ Store, Tag, Catalog○ Conformance○ Documentation
● Processing○ Workflow Documentation○ Reproducibility○ Standard Terminologies and Formats
● Release○ Access for Others○ Versioning○ Compliance with Global Data Standards
● Re-Use○ Access policies○ Use by Others○ Cite the Source
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Stakeholder Relationships
• Who are the stakeholders and the people around us?• There are lots!
Safety Science
ClinicalScience Statistics Medical
Writing Managers
Regulatory Study Management
Submission Teams
Standards Groups
DataManagement
Business Partners
Tools Processes Systems
RWD
Data Acquisition
MS / PK
IDCCs
IDMCs Biometrics Teams
Health Authorities
Other Companies
Your Project Lead
Statistical Programming
Study Lead
and even more...
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Stakeholder Relationships
Curious and Trusted Partner
Vision:
We drive and continuously evolve Analytics to generate Insights from Healthcare Data to improve Patient Lives
Proactively collaborate with Stakeholders Think ahead as influential Partner to drive Analytics
that advance Drug Development 17
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Stakeholder Relationships
• Be an equal Partner• Know the Disease / Molecule• Be pro-active• Offer alternative Ways of Analyses• Communication• Discussion• Understanding• Speak the same Language• Plan together• Make yourself visible• Guide your Stakeholders• Be curious and ask Questions• Show your Expertise• Drive Things
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Conclusions
• The future for Statistical Programming is much more than just technical up-skilling• Statistical Programmers need to be aware that there is really much more• Data F.A.I.R.ness, our Mindset and Stakeholder Relationships are just three Aspects• → although being very important ones!
• “Be an equal Partner and drive / shape Drug Development”
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Q&A
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