Wesley Allen Hall

714-***-****

ac4qhf@r.postjobfree.com

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