Associate Director Expert eData & Submission Analyst - Bayer Corporation

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Associate Director Expert eData & Submission Analyst  

Bayer U.S. LLC's Whippany, NJ, office seeks an Associate Director Expert eData & Submission Analyst . This is a hybrid office-based/work-from-home position to support the electronic submission of clinical data packages to various worldwide health authorities [US, Japan, Europe, China,  Canada, etc.] and other external parties as it relates to data transparency initiatives. Will also: (i) program and validate electronic data submission packages (SDTM, ADaM, legacy formats) and related reports; (ii) represent the Statistical Programming function in meetings and audits with global health authorities and internal teams; (iii) lead tool design/ process design for creation and validation of clinical data packages submitted to health authorities in support of drug applications and data transparency initiatives.

This is a hybrid office-based/work-from-home position within the United States. The employee can work remotely from within the United States, but must be able to work in the Whippany, NJ, office three (3) days per week.

Must have a master’s d egree (or foreign equivalent degree) in Health Care Management and Policy, Statistics, Mathematics, Biology, Ecology, or a related field plus five (5) y ears of experience in a related position.

Experience must include five (5) years working with: (i) systems and tools for statistical analysis, e.g., SAS, R, Python; (ii) processing of global health authority submissions and representing company in health authority audits; (iii) designing and implementing tools and macros to support eData submissions, health authority audits, and data transparency work; and (iv) health authority requirements for eData submission and data privacy.

Experience can be concurrent.

This is a hybrid office-based/work-from-home position within the United States. The employee can work remotely from within the United States, but must be able to work in the Whippany, NJ, office three (3) days per week.

Apply at http://career.bayer.us, using code below or careers_us@bayer.com with resume, salary requirements, and reference to code below. ( Associate Director Expert eData & Submission Analyst)