Biostatistician
Resume:
Wesley Allen Hall
*******@*******.***
PROFILE
A highly motivated, Sr. Biostatistician seeking a position to utilize technical skills in multiple aspects of the medical device or pharmaceutical industry such as product development, bioprocessing, manufacturing process control, continuous improvement, complaint management, and statistical data analysis for products undergoing clinical research and trials. My experience with biological combination products, clinical diagnostics, degrees in Biology and Applied Statistics, and interpersonal skills provides a solid background to work in the design, development, manufacturing and monitoring of specialized medical devices and their processes.
SKILLS
Design of Experiments: multi-factorial, contrast, model adequacy, block designs, nesting
Biostatistical Analysis: regression analysis (linear, logarithmic, longitudinal), ANOVA, t-tests, chi-square analysis, Bland Altman, ROC
Statistical Applications: Minitab, SAS, R
Medical Device Applications: FDA and ISO GMP manufacturing requirements for biological products
Computer Applications: MS Excel, MS PowerPoint, MS Word
Multi-Tasking: Able to work on different projects on priority basis
Collaboration Skills: Work independently and as part of a team, excellent communication skills
Organization Skills: Able to organize work assignments to meet schedule goals, motivated to continuously learn and improve technical and business skills
WORK EXPERIENCE
Diasorin (formerly Focus Diagnostics): Cypress, California 05/2014 – 01/2018
Knowledge and use of CLSI guidelines and statistical Design of Experiments to develop clinical and non-clinical / analytical protocols for experiments and analyze resulting data
Clinical data analysis of LoD, Reproducibility, Clinical / Method Agreement, Cross-Reactivity, Microbial Inhibition, and Fresh vs Frozen sample performance
Review of applicable FDA regulations and ISO standards to assess process and/or product compliance
Interface to external statistical contractors/consultants
Statistical analysis plans for various needs
Trend analysis and setting of criteria
Data analysis for stability reports and expiry date justification/extension
Sampling plans for operational qualification, performance qualification and validations
Sampling plans for efficacy testing and non-conforming product detection
Documentation and procedure updates and maintenance to include statistical justifications
Ad-hoc analysis of manufacturing, product development, and complaint data
Multifunctional team member for protocol development and report review
Data Management for clinical trial data
Shire: La Jolla, Callifornia 08/2012 – 04/2014
Mixed Model variance component analysis to optimize testing plans with respect to variance reduction
Sample Size optimization to improve product yield with respect to R&D and QC testing feasibility
Set process action, alert and trend limits for manufacturing efficiency
Design of experiments for manufacturing process improvement
Process mapping, critical control points, quality control charting/analysis
Variable significance testing and model estimation through regression analysis, paired t-tests
Use of statistical applications and programming - SAS, Mini-tab, R
Member of process improvement teams
Statistical analysis plans for manufacturing improvement projects
Ad hoc data analysis for manufacturing bioprocessing engineers
Biostatisticis representative in manufacturing project meetings
Contributed to departmental procedures
Alere: San Diego, California 08/2010 – 05/2011
Statistician Intern
Sample Size Calculation
Coefficient of Variation Calculation
Orientation to R statistical programming
Reagent manufacturing process validation study
Becton Dickinson, and Company: Franklin Lakes New Jersey 11/2004 – 7/2005
Biostatistics & Clinical Data Management Intern
Assist in the preparation of databases for clinical trials of BD Medical segment products
Clinical trial data management in preparation for statistical analysis
Worked with project team to identify key variables for new ophthalmic project clinical trial design
Performed clinical data reduction (tables, graphs, charts, etc.) for project teams
EDUCATION
California State University, Long Beach 8/2006 – 05/2011
Master of Science in Applied Statistics
University of the Pacific, Stockton CA 8/2000 – 5/2004
Bachelor of Science, Major Biology, Minor Statistics
LEADERSHIP
USTA Team Captain
Eagle Scout, Troop 1 Huntington Beach – 2000
OTHER EXPERIENCE
City of Huntington Beach 2007 - 2013
•Tennis Teaching Professional
Fountain Valley High School 2006 - 2010
•Junior Varsity Tennis Coach (Girls & Boys)
Edison High School 2011 - 2012
•Junior Varsity Tennis Coach (Boys)
•Assistant Tennis Coach (Girls)
REFERENCES
Available upon request
Contact this candidate