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Pharmaceutical Principal Statistician

Job Description

With a successful track record in both the CRO and resourcing fields, Ockham is driven by outcome, defined by expertise. For more information about Ockham, visit www.ockham.com.  One of our clients in San Francisco, CA is looking for a Principal Statistician. This is a contract position.

The Principal Statistician is a skilled statistician with training and significant experience in statistics, drug development, and clinical research. This person will provide biostatistics and biometrics leadership and oversight for all phases of clinical trials and drug development programs, including regulatory submissions.

•Works with clinical scientists, statistical programmers, clinical operations, and other statisticians to plan clinical studies, and to analyze and interpret clinical study data.
•Participates in new drug development programs as a Subject Matter Expert (SME) in statistics area.
•Responsible for production of the following study-related deliverables.
•Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.

Job Requirements

Minimum educational degree is a M.S. or Ph.D. in Statistics or Biostatistics.

A minimum of 5 years clinical trial experience in pharmaceutical and/or Biotech Company.

•Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (eg, SAS).

•Must have worked on statistical analysis plans, study protocols, clinical study reports; and preferably, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports).

•In-depth knowledge of clinical operations, data management, and clinical study report preparation workflow.

•Advanced knowledge of theoretical and applied statistics.

•In-depth knowledge of statistical analysis methods and results/data presentation formats of clinical data.

Job Snapshot

Post Date 8/28/2014
Location San Francisco, CA
Employment Type Contractor
Job Type Biotech, Pharmaceutical
Education 4 Year Degree
Experience 5 to 10 years
Manages Others No
Industry Biotechnology, Pharmaceutical
Required Travel Not Specified
Job ID 5616
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