Summary
Overview
Work History
Education
Skills
Certification
Publications
Timeline
Generic
Prabha Narayanaswamy

Prabha Narayanaswamy

Seattle,WA

Summary

Experienced Biostatistics leader with over 10 years of work experience in the industry managing clinical trials . Applied statistical programming methods using SAS and R. Motivated team leader with a passion to mentor and develop the team. Worked with medical directors, data managers to meet company goals using consistent and efficient programming practices. Committed to the advancement of equity, equality, and diversity to foster a positive and inclusive work environment.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Manager, Statistical Programming

Seattle Children's Therapeutics
09.2021 - Current
  • Working in Seattle Children's Therapeutics Immunotherapy to find cures for pediatric cancers using CAR T cell therapy, managing up to 13 ongoing trials
  • Managing a team of statistical programmers; Providing direction and mentoring.
  • Applying strong leadership talents and problem-solving skills to maintain team efficiency and pioneered automation of TLFs and validation for regulatory reporting such as DSMB, IND, IB, Pharmacovigilance projects using CDISC standard ADaM datasets
  • Developing documentation through SOPs and establishing procedure controls
  • Coordinating dose assignment and dose escalations for treatment regimens based on protocol
  • Managing and coordinating data requests and data transfer processes with external collaborators
  • Consistently achieving results by working with staff to meet established targets

Senior Statistical Programmer

Seattle Children's Therapeutics
09.2018 - 09.2021
  • Expertise in statistical programming, data management, and statistical analysis in clinical trials to find cures for childhood cancers using cutting-edge CAR T-cell therapy.
  • Lead programmer on up to 12 clinical trials.
  • Responsible for generating TLFs to produce DMC and IND reports for Phase I/II clinical trials.
  • Developed standard programming algorithms to automate report production and investigators brochure.
  • Responsible for FDA submission reports.
  • Review CRFs to determine CDISC and ADaM compliant datasets.
  • Responsible for creating standard processes, department guidelines and work instructions.

Senior Biostatistician

University Of Michigan
01.2013 - 2018
  • Primary study biostatistician at Department of Ophthalmology and Visual Sciences at Kellogg Eye Center responsible for performing statistical analysis and providing expertise in study design, sample size calculation, manuscript writing, natural language processing (NLPs) on EPIC dataset extracts using SAS
  • Primary biostatistician at Transportation Research Institute, University of Michigan to evaluate driving behavior from automated big data collection systems installed in cars, assess seatbelt safety systems, helmet law, and child passenger safety.
  • Statistical Consultant at Office of Highway Safety Planning, Michigan State Police to reduce fatalities and injuries on roadway crashes and provide supporting data presentations and analyses to law enforcement to help with planning and strategizing enforcement campaigns specifically for distracted driving, young driver safety etc.

Biostatistician

MPI Research
04.2011 - 04.2012
  • Performed statistical analysis on animal toxicology, cardiovascular and fertility studies, creating study databases, producing and validating reports, statistical presentations to leadership.
  • Primary programmer responsible for creating TLFs for study protocol and reporting
  • Validating reports and data of primary programmer

Biostatistics Research Associate

Grand Valley State University
08.2010 - 04.2012
  • Worked with Kirkhof College of Nursing and Grand Rapids Medical Education Partners to perform survey questionnaire design and statistical analysis on health-care and osteoporosis survey data to assess reliability and validity measures.
  • Supported students in undergraduate course with SAS Programming and SAS tutoring, course planning, assisting professors with assignment grading.

SAS Data Analyst

UE Life Sciences
06.2008 - 06.2010
  • Worked with clients in oncology, medical instrumentation and pharmaceutical industries to design clinical trials with complex statistical analysis, protocol writing, CRF review, TLF generation and report validation. Consistently met targets in timely manner for submitting regulatory reports.

Education

MBA - Data Analytics

Texas A&M University - Corpus Christi
Corpus Christi, TX
2024

Master of Science - Biostatistics

Grand Valley State University
Allendale, MI
2012

Bachelor of Science - Biotechnology

SRM University
Chennai, India
2008

Skills

  • Statistical Analysis using SAS, SPSS, R, Stata
  • Survival Analysis
  • Data Visualization
  • Data Reports and Templates
  • Python
  • Data Science
  • Machine Learning
  • Leadership/Budget allocation/Resource Planning/Goal Planning

Certification

Machine Learning by Stanford University at Coursera

Clinical Data Management

BASE SAS

Data Science Certification Training

Advanced Survey Methodologies

CDISC ADaM - Principles, Rules and Complex Examples

CDISC ADaM - Implementation by Example

CDISC, ADaM, SDTM and TLF

Publications

Stein JD, Rahman M, Andrews C, et al. Evaluation of an Algorithm for Identifying Ocular Conditions in Electronic Health Record Data. JAMA Ophthalmol. Published online February 21, 2019137(5):491–497. doi:10.1001/jamaophthalmol.2018.7051


Sandra C. Ganesh, Kalpana Narendran, Jeyanthi Nirmal, Vijayakumar Valaguru, Sangeetha Shanmugam, Nish Patel, Prabha Narayanaswamy, David C. Musch & Joshua R. Ehrlich (2018) The key informant strategy to determine the prevalence and causes of functional low vision among children in South India, Ophthalmic Epidemiology, 25:5-6, 358-364, DOI: 10.1080/09286586.2018.1489969


Jermakian JS, Klinich KD, Orton NR, Flannagan CAC, Manary MA, Malik LM, Narayanaswamy P (2014) Factors affecting tether use and correct use in child restraint installations. Journal of Safety Research 51:99-108.

H. Xiong, P. Narayanaswamy, S. Shan, C. Flannagan, J. Sayer, How Do Drivers Behave during Indecision Zone Maneuvers, Accident Analysis and Prevention (2015), DOI: 10.1016/j.aap.2015.04.023

Flannagan, C., LeBlanc, D., Bogard, S., Nobukawa, K., Narayanaswamy, P., Leslie, A., Lobes, K. (2016, February). Large-scale field test of forward collision alert and lane departure warning systems (Report No. DOT HS 812 247). Washington, DC: National Highway Traffic Safety Administration.


Jingwen Hu, Kathleen D. Klinich, Miriam A. Manary, Carol A. C. Flannagan, Prabha Narayanaswamy, Matthew P. Reed, Margaret Andreen, Mark Neal & Chin-Hsu Lin (2017) Does unbelted safety requirement affect protection for belted occupants?, Traffic Injury Prevention, 18:sup1, S85-S95, DOI: 10.1080/15389588.2017.1298096


Hu, J., Klinich, K. D., Manary, M. A., Flannagan, C. A. C., Narayanaswamy, P., Reed, Lin, C-H. (2016, January). Evaluation of belted and unbelted safety requirements (Report No. DOT HS 812 232). Washington, DC: National Highway Traffic Safety Administration.


Acknowledgement - Klein, K.F., Hu, J., Reed, M.P. et al. Ann Biomed Eng (2015) Development and Validation of Statistical Models of Femur Geometry for Use with Parametric Finite Element Models. Springer Link, 43: 2503. https://doi.org/10.1007/s10439-015-1307-6

Timeline

Manager, Statistical Programming

Seattle Children's Therapeutics
09.2021 - Current

Senior Statistical Programmer

Seattle Children's Therapeutics
09.2018 - 09.2021

Senior Biostatistician

University Of Michigan
01.2013 - 2018

Biostatistician

MPI Research
04.2011 - 04.2012

Biostatistics Research Associate

Grand Valley State University
08.2010 - 04.2012

SAS Data Analyst

UE Life Sciences
06.2008 - 06.2010

MBA - Data Analytics

Texas A&M University - Corpus Christi

Master of Science - Biostatistics

Grand Valley State University

Bachelor of Science - Biotechnology

SRM University
Prabha Narayanaswamy