Prabha Narayanaswamy

Portfolio Strategy: Spearhead the statistical programming lifecycle for a high-priority portfolio of 15+ concurrent pediatric immunotherapy trials focused on CAR T-cell innovation.
Functional Leadership: Direct and mentor a cross-functional team of Statistical Programmers, Data Managers and Biostatisticians, fostering technical excellence and professional growth.
Operational Architecture: Pioneered an automation framework for TLF generation and validation, accelerating delivery for DSMB, IND, IB, and Pharmacovigilance reporting using CDISC-standard ADaM datasets.
Clinical Governance: Coordinate complex dose assignment and escalation rules for treatment regimens based on active study protocols.
Vendor & Stakeholder Management: Lead strategic data transfer processes, CRF builds and coordination with external collaborators and vendors to ensure data integrity and cost-effective delivery.
Process Engineering: Establish rigorous procedural controls and author comprehensive SOPs to ensure 100% audit readiness and standardized programming practices.

Regulatory Submissions: Acted as Lead Programmer for 12 clinical trials, delivering comprehensive TLF packages for Phase I/II DMC and IND regulatory reports.

Submission Excellence: Directly responsible for the accurate and timely delivery of FDA submission reports.

Data Standardization: Reviewed Case Report Forms (CRFs) to ensure end-to-end CDISC and ADaM compliance for all trial datasets.

Strategic Study Design: Served as the primary study biostatistician for the Kellogg Eye Center, providing executive-level expertise in study design, sample size calculations, and advanced statistical modeling for clinical manuscripts.
NLP & EHR Innovation: Leveraged Natural Language Processing (NLP) techniques on complex EPIC electronic health record (EHR) dataset extracts using SAS to drive clinical research insights.
Big Data Analytics: Directed the statistical evaluation of large-scale automated data collection systems for the Transportation Research Institute to assess the efficacy of seatbelt safety, child passenger protection, and helmet laws.
Public Safety Consulting: Acted as a lead Statistical Consultant for the Michigan State Police, translating high-volume crash data into strategic enforcement campaigns for distracted driving and youth safety.
Interdisciplinary Impact: Partnered with law enforcement and academic researchers to deliver data-driven presentations that influenced state-wide safety planning and injury reduction strategies.

Preclinical Statistical Oversight: Performed comprehensive statistical analysis for animal toxicology, cardiovascular, and fertility studies, ensuring data-driven insights for early-phase research.
Database Architecture: Spearheaded the creation and management of study databases to ensure robust data capture and structural integrity for preclinical protocols.
Technical Reporting: Served as the primary programmer responsible for the architecture and generation of Tables, Listings, and Figures (TLFs) in strict accordance with study protocols.
Quality Assurance & Validation: Executed rigorous independent validation of peer-programmed reports and datasets to maintain high-quality standards and regulatory readiness.
Executive Presentations: Synthesized complex statistical findings into actionable reports and presentations for senior leadership to support study decision-making.

Research Methodology & Design: Partnered with the Kirkhof College of Nursing and Grand Rapids Medical Education Partners to engineer survey instruments and study designs for healthcare and osteoporosis research.
Psychometric Analysis: Conducted rigorous statistical analysis to assess the reliability and validity of clinical survey data, ensuring high-quality psychometric properties for medical research initiatives.
Technical Mentorship: Provided expert-level SAS Programming instruction and tutoring for undergraduate courses, facilitating student mastery of complex statistical software.
Academic Operations: Collaborated with faculty on course architecture, curriculum planning, and the evaluation of advanced statistical assignments.

Clinical Trial Lifecycle Support: Partnered with diverse clients across the Oncology, Pharmaceutical, and Medical Device sectors to support the design and execution of Phase I/II clinical trials.
Protocol & CRF Development: Contributed to the development of clinical study protocols and conducted thorough Case Report Form (CRF) reviews to ensure data collection aligned with statistical analysis plans.
Production Programming: Developed and maintained SAS programs to generate Tables, Listings, and Figures (TLFs) for high-stakes regulatory submissions and clinical study reports (CSR).
Rigorous Validation: Executed independent double-programming and validation of primary datasets and outputs to ensure 100% accuracy and compliance with internal and regulatory standards.
Regulatory Momentum: Consistently achieved aggressive milestones for the timely delivery of regulatory data packages.