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
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Generalized
Linear Mixed Models
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ANOVA/ANCOVA
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Multivariate
Analysis
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Survival
Analysis
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Crossover
Trial Analysis
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Randomization
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Sample
Size
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Multiplicity/Interim
Analysis
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Subgroup
Analysis
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Binary
Response Data Analysis
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Stability
Analysis
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Monte
Carlo Simulation
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Design
of Experiments
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Bayesian
Methodology
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Capability
Analysis
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Software/Programming
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SAS
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R
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Python
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MatLab
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C/C ++/CUDA
C
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Visual
Studio
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Linux
(multiple distributions)
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Windows and
Office Applications
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Oracle
Virtual Box
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SQL
Database Management
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Shell
Scripting
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Latex
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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
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Regulus
Therapeutics,
Inc.
(through
SimulStat, Inc.)
Biostatistical
Consultant, 2017-present
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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.
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Agility
Clinical, Inc.
Manager,
Biostatistics, 2013-2015
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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.
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Althea
Technologies, Inc.
Supervisor,
QC Stability, 2008-2013
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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.
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Favrille,
Inc.
Quality
Control Analyst IV, 2004-2008
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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.
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IDEC
Pharmaceuticals, Inc.
Biochemist
II, 2002-2004
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Routine
stability testing of immunological and radioimmunological
products.
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Matrix
Pharmaceuticals, Inc.
Quality
Control Chemist, 2001-2002
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Routine
laboratory testing of manufactured drug substances and drug
products.
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