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Biostatistician manager

Vicente Lopez

Ned.Vicente@gmail.com

 

 

Personal Summary

A Problem Solver and Process Improvement Developer

The way I approach work is to solve problems as they arise and not let problems grow into larger problems. I look for solutions that will provide long-term benefits and will meet short-term needs.

I constantly look at the processes that are currently being used and try to find improvements. Improvements could be in the form of applications, processes, procedures or training.  Improvements are almost always a team effort, so it is very important to me to get acceptance before implementing improvements.

Skills Summary

Experience in providing the following statistical support:

• Study design,
• Sample size estimation,
• Writing statistical sections of protocols,
• Creating statistical analysis plans,
• Designing and programming statistical analysis datasets,
• Designing and programming statistical listings, tables and figures,
• Exploratory data analyses, and
• Providing statistical consultations to other departments.

Ability to program in the following languages:

• SAS (macro, data null, proc report, wide variety of statistical procedures, ODS output)
• SQL
• Visual Basic

Professional Experience

 

Cempra Pharmaceuticals, Chapel Hill, NC

Manager, Biostatistics and Database Programming (Apr 2005 – Present)

Sr. Clinical Biostatistician (Aug 2002 – Mar 2005)

As the Manager of the Biostatistics and Database Programming group, I am responsible for the management and reviewing of all tasks assigned to the group. These tasks include:

·         Mapping datasets from the TKL Data Entry System into datasets that can be used by Data Management and Biostatistics,

·         Programming Data Management’s edit checks,

·         Providing support programming for Data Management (edit listings, audit sheets and other various listings),

·         Generating statistical analysis datasets, and

·         Generating statistical tables, listings and figures.

I am responsible for the training and professional development of the personnel in my group and assisting in the training of Data Management personnel.

As the most senior statistician, I am responsible for writing/reviewing statistical sections of protocols, CRF design review, data management plan review, writing/reviewing statistical analysis plans (SAPs), reviewing and consulting with medical writers on statistical reports, generating statistical tables and listings, managing project timelines and providing statistical consultation services to clients.

Key Accomplishments:

·         Managed timelines,

·         Authored statistical sections of protocols,

·         Authored statistical analysis plans,

·         Programmed statistical listings, tables and figures,

·         Developed complete statistical analysis services (assisted with protocol development / SAP / programmed tables and listings / reviewed statistical sections of the reports / interacted with the FDA / answered FDA reviewer’s questions) for 8 NDA submissions, and

·         Created a Biostatistics and Database Programming Group (currently consists of 3 people).

Erimos Pharmaceuticals, Raleigh, NC

Assistant Director – SAS Applications Group

Feb 1999 – Aug 2002

Key Accomplishments:

·         Created a standardized data structure.

·         Created a library of SAS Macros (data conversion macros, data analysis macros and data reporting macros).

·         Created an application that would assist in the generation of statistical tables.

·         Created an application that would assist in the generation of Data Management usable output.

Burns Adler Pharmaceuticals, Charlotte, NC

Assistant Director, Biostatistics and Data Management

Mar 1996 – Jan 1999

Key Accomplishments:

·         Grew the office from 12 individuals to 70 individuals.

·         Provided necessary training for newly hired individuals.

·         Grew the number of clients from 1 to 5.

·         Designed and assisted in the development of 2 Edit Check.

 

 

Education

Masters of Science, Theoretical Statistics

Elon University

Elon, NC

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