Standards-Driven Statistical Science Portfolio
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Statistical Science
Programming & Data Standards
Credly
Programming & Data Standards
Outputs
Alpha TRAORE
Senior Statistical Scientist
Home
Statistical Science
Scientific Leadership and Positioning
Statistical Study Leadership
Trial Design, Estimands, and Planning
Study Design Overview
Estimands and Intercurrent Events
Sample Size and Power
Randomization and Blinding
SAP and TLF Shells
Confirmatory Inference and Robustness
Multiplicity
Missing Data
Sensitivity Analyses
Statistical Modeling
Modeling Methods
Modeling Overview
MMRM
Survival Analysis
PK/PD
Quality, Validation, and Delivery Readiness
QC and Validation
Programming & Data Standards
SDTM
SDTM Overview
Domains (with Specs)
SDTM DM (Demographics)
SDTM AE (Adverse Events)
SDTM VS (Vital Signs)
Submission Package
Case Report Forms
Outputs
Define XML
SDRG
Build & Quality
Programs
Validation Summary
QC
Standards
ADaM
ADaM Overview
Domains (with Specs)
ADaM ADSL (Subject-Level Analysis Dataset)
ADaM ADAE (Adverse Events Analysis Dataset)
ADaM ADVS (Vital Signs Analysis Dataset)
ADaM ADTTE (Time-to-Event Analysis Dataset)
Submission Package
Outputs
Define
ADRG
Build Quality
Programs
Validation
QC
Standards
TLFs
TLF Overview
Tables
Table 1: Demographics
Table 2: TEAE by SOC/PT
Table 3: Table 3: PFS Summary
Table 4: Table 4: ORR
Table 5: Heart Rate Change
Figures
Figure 1: Cumulative Incidence Function (CIF) Plot (PFS)
Figure 2: PFS Kaplan–Meier
Figure 3: BMI Over Time by Treatment
Listings
Listing 1: Demographics & Baseline (Analysis Set)
Listing 2: TEAEs by SOC/PT
Listing 3: ORR
Programming & Data Standards
Outputs
Outputs
Case Report Forms
Define XML