EXPERIENCE
9/2008 to 10/2009 Premier Research Group, Ltd, San Diego, CA
Senior Biostatistician
Led the ISS portion for an eCTD NDA submission in a two month timeframe,
from start to finish, including managing 6 programmers (direct reports),
communicating with data operations regarding SDTM conversion of operational data,
confirming ADaM compliance for all analysis data, collaborating with outside
vendors specific for creating Define.xml documents, converting data to XPT
format, and internal communication with Medical Writing and senior staff
regarding decisions on timelines, report methods, and outstanding issues
pertaining to data and/or statistics.
Wrote and/or reviewed company-wide Working Guidelines and Standard Operating
Procedures to standardize processes and regulatory components for the global
biostatistics and SAS programming group.
Collaborated with senior and upper management in regards to project flow,
billable hours, contract updates, and assessing timelines for deliverables of all
validated product (both within and outside biostatistics).
Responsible for writing Statistical Analysis Plans (SAP) for multiple clients
and studies, as well as review Sponsor written SAPs for statistical validity and
interpretability for the study objectives. The SAP includes all related Tables,
Listings, and Figures, as required by regulatory agencies, and clinical study
report needs.
Provide review and input for Case Report Forms (CRFs) for proper data capture
in relation to both data management and statistical analyses.
Create ADaM compliant Analysis Database Documentation (AnDD) for all analysis
databases needed for efficacy, safety, and patient disposition analysis.
Manage teams of SAS programmers to meet client deliverables in relation to
study product, analysis database programming, and TLF programming.
Currently program quality control programs to verify both analysis databases
and TLF output for validity, and for consistency with study objectives and the
AnDD.
Provide training for new employees on statistical development and procedures
needed for client activity.
4/2007 to 8/2008 Pacific Data Designs San Francisco, CA
Project Biostatistician
Was responsible for writing Statistical Analysis Plans (SAP) for multiple
clients and studies, as well as reviewed Sponsor written SAPs for statistical
validity and interpretability for the study objectives. The SAP included all
related Tables, Listings, and Figures, as required by regulatory agencies, and
clinical study report needs.
Provided review and input for Case Report Forms (CRFs) for proper data capture
in relation to both data management and statistical analyses.
Reviewed information provided by data management, such as data dictionaries
and data management plans.
Created ADaM compliant Analysis Database Documentation (AnDD) for all analysis
databases needed for efficacy, safety, and patient disposition analysis.
Managed teams of SAS programmers and data coordinators to meet client
deliverables in relation to data cleaning and database lock, analysis database
programming, and TLF programming.
Programmed quality control programs to verify both analysis databases and TLF
output for validity, and for consistency with study objectives and the AnDD.
Led a team of SAS programmers and statisticians for CDISC Study Data
Tabulation Metadata conversion of all operational data provided by clinical sites
on CRFs, as well as created the data dictionary, similar to the AnDD, for the
SDTM to operational linked data.
Provided information regarding regulatory requirements for submission of
various phases of trials (FDA, ICH), in both pharmaceutical and medical device.
Provided all ad-hoc analyses, per the request of both Sponsors and
departmental statisticians. These typically were in relation to ISS/ISE or CSR
submissions.
Provided training for new employees on statistical development and procedures
needed for client activity.
Performed statistics and provide support in a variety of different therapeutic
areas, including (but not limited to) oncology, pain management, medical device
products, cosmetic pharmaceuticals, infectious diseases, on all phases of
clinical trials.
5/2006 to 2/2007 Nellcor Puritan Bennett Pleasanton, CA
Senior Biostatistician
Performed statistical analysis on pre-market studies, post-market studies,
and in-house studies performed in the clinical laboratory and clinical sites.
Provided guidance and statistical consultation within the department on
clinical protocols, data management procedures, and clinical studies.
Was responsible for writing operating procedures to standardize data
management for clinical trials, both on-site and on location, per FDA regulations
on data management and collection.
Provided guidance on designing case report forms (CRFs) for all clinical
studies.
Provided statistical guidance and analysis across departments for research and
development studies.
Was responsible for writing statistical analysis plans (SAPs) for clinical
studies, in-house studies, post-market studies, and research and development
studies.
7/2005 to 5/2006 Genomic Health, Redwood City, CA
Project Biostatistician
Performed statistical analysis on key Validation Studies performed by the
Commercial Reference Laboratory.
Provided guidance and statistical consultation to Research and Development in
order to assess feasibility for the development of a new product or new method.
Designed and led validation studies to qualify incoming machines to be used in
the Commercial Reference Laboratory.
Was responsible for writing regulatory reports of validation studies,
feasibility studies, and any non-conformance seen during the course of any study
conducted through the Commercial Reference Laboratory.
Was responsible for writing SAS process monitoring programs to be used, in
compliance with CLIA standards for process monitoring commercial patient
laboratories.
4/2003 to 1/2005 Clinical Micro Sensors, Pasadena, CA
Senior Biostatistician
Performed statistical analysis on key Digital Six Sigma projects, analyzing
data and presenting results in Power Point.
Maintained data from different aspects of the company, such as Manufacturing,
Research and Development. Create a subset of a data repository both in JMP and
SAS to be uploaded into a larger data repository maintained in Oracle.
Interacted in a Project Team environment in collaborative efforts to design
experiments for internal verification.
Automated data management and analysis processes for experimenters and
scientists to allow autonomy in experiments.
Maintained on-going training in statistical analysis and design of experiments
in JMP for all levels of experimenters (beginning, intermediate, advanced).
Provided consulting on projects outside of Assay Development to advise
scientists on design of experiments, sample size needed, power calculations, and
types of analysis needed.
Provided consulting on designing the database and repository in Oracle, where
data would be accessed from different data structures already present in the
company. The data repository acted as a storing warehouse, linking information
between various components of the product. Queries would be written both in SAS
and Oracle, to subset data for further analysis and troubleshooting to be
performed.
Was responsible for writing up documents (Standard Operating Procedures,
Experiment Reports) that would be reviewed by the FDA during submission of the
product.
Maintained statistical documents in Assay Development for future use by other
departments.
9/2002 to 3/2003 City of Hope National Medical Center, Duarte, CA
Programmer/Analyst
Conducted a longitudinal study using NIH Surveillance, Epidemiology, and
End-Results (SEER) data on stomach cancer patients. This was a longitudinal
study of patients who had completed surgery and had lymph node dissections.
Comparisons were made based on tumour classification, as well as nodal staging
(American Joint Committee on Cancer (AJCC) staging used).
Created reports of missing data taken from the National Marrow Donor Program
(NMDP) forms. These reports were for use by Clinical Research Associates, to
detect patient missing data, and to correct patient information as needed. I
also wrote reports of missing data for disease specific forms, not related to
NMDP.
Listed data for haematology transplant patients under auspices of the COH
Institutional Review Board (IRB). This project required identifying protocols
that required Health Insurance Portability and Accountability Act (HIPAA)
amendments and reconsenting of patients.
Performed statistical analysis on outcomes of cholecystectomy patients
(surgery to remove the gall bladder). Compared patients that had open,
laparoscopy, or conversion surgery. Comparisons were made for recovery post-op,
complications, and survival.
Wrote toxicity reports for medical oncology data using SAS PROC REPORT. These
reports were split out by attribution of toxicity.
Created and updated breast cancer database from Southern California cancer
registry to examine outcomes in patients receiving surgery.
Compiled and merged excel files, containing cytogenetic information
(cytogenetics involves the study of the structure of chromosomes. In this case,
it was genetic mapping). This file was imported into SAS to create a SAS
dataset, to be used for further analysis, and later use.
Analyzed patient safety data from a campus-wide survey study of all
employees.
Conducted a cross-sectional study of patients who were surgery candidates for
palliative surgery. Tabulated patterns of readmission and encounters,
correlating surgery outcomes based on demographics, diagnosis, and clinical
data.
9/2001 to 6/2002 UCLA School of Public Health, Los Angeles, CA
Student Research Assistant, Department of Epidemiology
Model building for survival among patients with end stage dementia.
Data collected independently from hospices, and then manipulated using SAS.
Statistical analysis and model building is done using Stata.
The models were based on co morbidity in patients, as well as similar
standards to Medicare for hospice enrollment (such as cognitive decline).
6/1998 to 10/2001 Quality Systems, Inc, Tustin, CA
Customer Support Representative/Programmer Analyst
Provided technical support on AIX servers for clients to maintain large data
base files for hospitals and medical/dental offices.
Wrote data integrity programs to look for potential problems with data, or
correct any problems already found in data.
Maintained programming on applications that would error.
Helped clients with national and state medical standards for billing insurance
claims.
THERAPEUTIC EXPERIENCE
Analgesics (US)
Analgesic pain relief for subjects suffering from lesions associated with HIV
Opioid therapy for pain relief in subjects with a history of opioid abuse
IV Acetaminophen for the treatment of postoperative pain after abdominal
laparoscopic surgery Phase III
Cognitive Therapy (Global)
Oral Dimebon in Patients with Mild-to-Moderate Alzheimers Disease Phase
III
Medical Device (International / US)
Stent placement in the revascularization of lesions located in the limb
Micro Chip technology for the use of diagnostics for presence of Cystic
Fibrosis for pre-natal determination Feasibility
Feasibility and Efficacy
EDUCATION
2002 Masters Degree of Public Health, Biostatistics
UCLA School of Public Health
Los Angeles, CA
1998 Bachelors Degree of Arts in Mathematics, Concentration in
Statistics/Probability
Minor in Computer Science
California State University, Fullerton
Fullerton, CA
COMPUTER SKILLS
Software: SAS (V9.1), JMP (V5.1), S-Plus, Stata, Minitab, Matlab, Mathematica
Programming: C/C++, Pascal
Operating Systems: UNIX/Linux/AIX, Windows 95/98/2000/NT
General Applications: Microsoft Office
PROFESSIONAL AFFILIATIONS
American Statistical Association (2002)
Psi Beta Honour Society
American Women in Mathematics
Institute of Mathematical Statistics
PUBLICATIONS
Smith DD, Schwarz RR, Schwarz RE. Optimal Number of Lymph Nodes to Dissect
after Surgery for Cancer of the Stomach submitted to Cancer, March 2003.
James T Kakuda, David Smith, Rebecca R Schwarz, Lawrence D Wagman and Christian
DeVirgilio. 156: The Implications of Male Gender on Outcomes of
Cholecystectomy. Journal of Gastrointestinal Surgery, Volume 7, Issue 2,
February 2003, Page 307.
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