Senior Lead Biostatistician

San Francisco  ‐ Onsite
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Keywords

Description

Senior Lead Biostatistician

Located in San Francisco Bay Area, we are looking for a team lead who will be providing biostatistical support for clinical studies in therapeutic areas, working on FDA submissions, and collaborating cross functionally.

-Create sample size calculations, creation of statistical analysis plans (SAP), SAS programming of tables, listings, figures, providing review and input into protocols and any statistical analysis of the clinical data for support of the Clinical Study Reports, and participating in client meetings.

-Write analysis plans and statistical reports for clinical studies, use SAS to generate tables, listings, graphs, and to perform statistical tests as outlined in the statistical analysis plan.

- Work to the specifications in related SOPs and guidelines, and manage multiple projects.

- Participate in the business unit's operational effectiveness efforts to improve the efficiency of study conduct, data management, and data quality processes in clinical studies.

- Lead statistical team in developing specifications for the database design to assure quality.

- Interact with FDA reviewers to negotiate optimal study designs, to explain the quantitative results of clinical studies and to defend the analytical approach and interpretation of models used.

Education/Experience

Minimum M.S. in Statistics, Biostatistics or related field (7+ years)

Ph.D preferred (4+ years)

To find out more about Real please visit www.realstaffing.com
Start date
11/2013
From
Real Staffing
Published at
29.09.2013
Project ID:
606152
Contract type
Permanent
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