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POST DATE 9/15/2016
END DATE 11/8/2016
Bracco Diagnostics, Inc.
Monroe Township, NJ
JOB DESCRIPTIONBracco Diagnostics Inc. specializes in the clinical development, marketing and sales of diagnostic contrast imaging agents and primarily markets its products to hospitals throughout the United States. Bracco Diagnostics Inc. is committed to the discovery, development, manufacturing and marketing of imaging agents and solutions aimed at providing a better use and management in terms of diagnostic efficacy, patient safety and cost effectiveness. Bracco Diagnostics currently has an opening for a Senior Statistician in our Monroe, NJ location.
SUMMARY: This role implements applied statistics and mentors BDI staff to develop and sustain capability for statistical justification and data driven decisions. This individual will collaborate with staff to apply sound statistical methodology and support value added decision making related to the following:
Pharmaceutical and Medical Device Compliance
Root Cause Analysis
Continued process verification
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following:
Comply with CGMPs, including 21CFR (Parts 210, 211, 11), EudraLex - Volume 4, and ISO13485
Apply statistical theories and methods to solve practical problems in business, engineering, pharmaceutical / contrast agent and medical device sciences.
Develop and apply statistical methods to solve practical problems in business, engineering, the sciences, or other fields.
Decide what data are needed to answer specific questions or problems
Determine methods for finding or collecting data
Analyze, interpret and report conclusions from their data analyses
Responsible for collection, analysis, interpretation, processing and presentation of numerical information relative to process validation in a cGMP regulated medical device manufacturing environment.
Leads or participates in the development and implementation of statistical models and sampling plans
Generates and analyzes control charts as part of periodic trend analysis and develops statistical reports
Mentors and serves as a statistical analysis subject matter expert for assigned projects and in support of regulatory audit.
Communicate statistical approach and analysis in an understandable manner
EDUCATION and/or EXPERIENCE REQUIRED:
Minimum (Required): Bachelor's degree or Master's degree, Chemistry or Engineering or equivalent combination of education and work-related experience.
Minimum (required): 5-10 years related experience in medical device, Biotech or pharmaceutical industry, including control process charting and application of statistical sampling plans.
Knowledge and experience in IVD, Pharmaceutical, and or Medical Device Industry; Industry Standards for Validation; Industrial Statistics, Federal cGMPs and QSRs, ISO 13485.
Excellent written and verbal communication skills with ability to multi-task are required.
Knowledge of statistical concepts and techniques, including modeling.
Excellent organizational skills and attention to detail
Ability to prioritize and effectively manage several projects simultaneously
Meet project deliverables and timelines from a statistical perspective
Work collaboratively within a multidisciplinary team
Knowledge of Minitab, SAS, SPSS and JMP