Sr. Principal Biostatistician

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POST DATE 8/31/2016
END DATE 10/26/2016

Novartis Oncology Cambridge, MA

Company
Novartis Oncology
Job Classification
Full Time
Company Ref #
360504
AJE Ref #
576029846
Location
Cambridge, MA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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The Statistician will be responsible for bioinformatic and/or statistical activities in support of Drug (Rx) and/or Companion Diagnostics (CDx) Development for the assigned drug programs within the Novartis Portfolio. As a member of the core Clinical Biomarker Sciences and Companion Diagnostics (CDSC) Biostatistics and Bioinformatics (BIOS) Team, he or she will provide strategic, scientific and technical input to the development of the corresponding Novartis products. CDSC - BIOS are key functions within OGD-GMA, providing strategic, scientific statistical support for OTM and OCD and/or CDx. Communication with development and regulatory teams as well as external partners through reports and presentations is an essential aspect of this work. The Clinical Biomarker Sciences (CBS) Statistician will support bioinformatic and statistical activities that enable the development and execution of the integrated biomarker strategies for Novartis Oncology programs. The CDx Statistician will provide statistical and data-analytic support for the design and subsequent analyses of molecular and clinical data from design verification, analytical performance characterization and clinical validation studies in conjunction with registrational clinical trial assays (rCTA) and IVD CDx device development and registration. The candidate will work with heterogeneous and cross functional teams of scientists, engineers, clinical and regulatory experts, responsible for the successful develop-ment of rCTA and CDx devices for Novartis programs. Particular emphasis will cover all statistical activities enabling the robust design, development and manufacturing of CDx products via Design For Six Sigma (DFSS) under design control, as well as demonstrating analytical and clinical performance in support of PMA filings as required by the FDA.. br br b EEO Statement /b br The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. br