Detailed Syllabus & Weekly Breakdown

Semester 1: Statistical Foundations & Trial Design

• Module 1: Foundations of Biostatistics (Weeks 1–9)
  • Week 1-3: Data types; Descriptive statistics; Probability distributions (Normal, Binomial, Poisson)
  • Week 4-6: Sampling distributions; Confidence intervals; Hypothesis testing (t-test, Chi-square, Fisher’s)
  • Week 7-9: Multiple Regression; R-Lab (data cleaning, scripts)
• Module 2: Trial Design & Data Architecture (Weeks 10–18)
  • Week 10-12: Trial designs (Parallel, Crossover, Factorial); Randomization & Blinding
  • Week 13-15: Endpoints & Estimands (ICH E9 R1); Sample size & Power
  • Week 16-18: GCP Ethics; Data flow; CDISC (SDTM/ADaM)

Semester 2: Advanced Analysis & Regulatory Deliverables

• Module 3: Statistical Methods for Clinical Trial Analysis (Weeks 19–27)
  • Week 19-21: Estimands; ANCOVA; Logistic regression
  • Week 22-24: Survival Analysis (Kaplan-Meier, Cox model)
  • Week 25-27: Longitudinal data (MMRM); Missing data & Sensitivity Analysis
• Module 4: SAP Writing, Reporting & Capstone (Weeks 28–36)
  • Week 28-30: SAP structure; Baseline derivations
  • Week 31-33: Multiplicity; Safety analysis (TEAEs, SAEs); TFL creation
  • Week 34-36: SPIRIT & CONSORT; Final Capstone + Viva

Learning Outcomes

• Design Expertise: Select endpoints and justify sample size
• Analytical Power: Perform statistical analysis using R/SAS
• Technical Writing: Draft regulatory-compliant SAP
• Reporting Excellence: Present results using TFLs

Assessment Weightage

Assessment Type	Weightage
Master Capstone & Viva	25%
Software Labs & Coding	20%
Written Assignments	20%
Module Assessments	20%
Quizzes & Tests	15%

The "WhiteCollar" Academic Rationale

This 9-month journey is the "Master's Equivalent" for the industry. By following the sequence of Foundations → Design → Analysis → Reporting, WhiteCollar Academy ensures graduates are not just number crunchers, but strategic biostatisticians capable of leading clinical trials end-to-end.