Curriculum Vitae

Edward H. Murphy

ehmst3@gmail.com • (619)846-9684 • https://edwardmurphy.github.io

Biostatistician, Statistical Programmer, Data Analyst, Quality Engineer, and Analytical Chemist

Summary of Expertise

Safety and efficacy analyses (design, execution, and summary) of clinical trials for IPs and medical devices at all phases (I-IV, including integrated studies and PK/PD) in therapeutic areas of diabetes, oncology, neurology, hepatology, nephrology, cardiovascular, respiratory, psychiatry, and vaccines

Use of statistical methodology for design and analysis of laboratory studies: study design using DOE principles, including defining process space; stability analysis; analytical method comparison, qualification and validation; statistical process control; development of specifications and manufacturing controls

CDISC standardized programming of SDTM and ADaM datasets and validation per Pinnacle 21

Process improvement and validation for manufacturing pharmaceuticals, biologics, and medical devices including use of large datasets of historical process output

Development of sampling schema for clinical trials, analytical methods, and manufacturing processes

Clinical and CMC sections of NDA and BLA submissions, clinical trial protocols and reports, SAPs, and miscellaneous technical documentation for regulatory filings

Team leadership of cross-functional groups including clients and other external stakeholders

Statistical Methodology Experience

Generalized Linear Mixed Models	ANOVA/ANCOVA	Multivariate Analysis
Survival Analysis	Crossover Trial Analysis	Randomization
Sample Size	Multiplicity/Interim Analysis	Subgroup Analysis
Binary Response Data Analysis	Stability Analysis	Monte Carlo Simulation
Design of Experiments	Bayesian Methodology	Capability Analysis

Software/Programming

SAS	R	Python
MatLab	C/C ++/CUDA C	Visual Studio
Linux (multiple distributions)	Windows and Office Applications	Oracle Virtual Box
SQL Database Management	Shell Scripting	Latex

Education

M.S., Statistics, San Diego State University (incl. Ph.D. coursework at Claremont Graduate University)

B.S., Neuroscience, University of Pittsburgh (Phi Beta Kappa)

Employment History

Regulus Therapeutics, Inc. (through SimulStat, Inc.) Biostatistical Consultant, 2017-present	Provide statistical consultation at all levels for 8 clinical trials for client developing Hepatitis C and kidney disease therapies. Assist with protocol development, study initiation, study simulation (including Bayesian methods), data management (including standardization of data per CDISC), review of SAP and TLFs, outputs for medical monitoring and conferences. Worked independently and reported directly to CMO. Supported bioinformatics projects.

Agility Clinical, Inc. Manager, Biostatistics, 2013-2015	Promoted from Biostatistician I to Manager within 9 months. Involved in all levels of statistical and programming support for award-winning CRO, including project management for external and internal stakeholders. Main statistician for ad hoc project work due to skill set (education and industry experience). Worked independently from project initiation (SAP development) through project completion (data deliverables and summary reports). Expertise in entire data programming process from raw data through creation of SDTM and ADaM datasets per CDISC.

Althea Technologies, Inc. Supervisor, QC Stability, 2008-2013	Lead team of HPLC analysts within department that generated over USD 1 million annually in revenue. Responsible for design of hundreds of analytical method validation protocols for products at various stages of clinical development and assay development. Formalized method transfer and qualification procedure, including sample size calculations, testing for equivalence and mixed modeling procedures for variance components analysis. Utilized discrete (Poisson, negative binomial) and continuous models in the analysis of microbiological and particulate data to set action and alert limits for manufacturing process controls. Collaborated with analytical and product development group to institute study designs based on DOE principles for process optimization and analytical method robustness evaluation.

Favrille, Inc. Quality Control Analyst IV, 2004-2008	Responsible for submission of all validation documents for BLA-related activities; supported CMC submission. Created and monitored statistical process control system for all relevant assays to determine assay acceptability, set system suitability specifications, and demonstrate lot conformance.

IDEC Pharmaceuticals, Inc. Biochemist II, 2002-2004	Routine stability testing of immunological and radioimmunological products.

Matrix Pharmaceuticals, Inc. Quality Control Chemist, 2001-2002	Routine laboratory testing of manufactured drug substances and drug products.

Page 1 of 2

blogroll

social