Senior Statistician

Job Description
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

* Responsible for collection, analysis, interpretation, processing and presentation of numerical information relative to process validation in a cGMP /CBER regulated medical device manufacturing environment.

* Leads or participates in process FEMA and implementation and validation of appropriate process controls. Generates and analyzes control charts to identify irregularities and errors.

* Leads or participates in the development and implementation of statistical models and sampling plans for application in validation.

* Generates and analyzes control charts as part of periodic trend analysis and develops statistical reports with data interpretation as part of the validation lifecycle (validation, monitoring, and revalidation).

* Serves as a statistical analysis subject matter expert for assigned projects.

* Must be able to communicate statistical approach and analysis in an understandable manner to people with little or no knowledge of statistics.
Requirements

Education:

* Bachelor's degree or Master's degree, in math, statistics or engineering, or equivalent combination of education and work-related experience, required.

* Master's degree, in math, statistics or engineering, preferred.

Other qualifications:

* Knowledge and experience in IVD, Pharmaceutical, and or Medical Device Industry; Industry Standards for Validation; Industrial Statistics, Ferderal cGMPs and QSRs, ISO 13485.

* Expert understanding of process FEMA, control charting and statistical process controls with a keen ability for identifying irregularities and errors. Must be able to communicate statistical approach and analysis in an understandable manner to people with little or no knowledge of statistics.

* Familiar with statistical packages like MiniTab.

* Excellent written and verbal communication skills with ability to multi-task are required.

Company

Roche

Job Code

State or Province

New Jersey

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