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Bayer Lead Cross Study Information Specialist in Whippany, New Jersey

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.

At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

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Lead Cross Study Information Specialist

Your tasks and responsibilities

Bayer U.S. LLC’s Whippany, NJ, office seeks a Lead Cross Study Information Specialist to build and maintain integrated databases.

The primary responsibilities of this role, Lead Cross Study Information Specialist, are:

  • setting-up, updating, and ongoing maintenance of integrated databases and set-up of related containers in Clinical Information Environment;

  • delivering of integration specific mappings, programs, views, and data deliverables to support integrated summaries of safety/efficacy, publications, LCM, etc.;

  • collaborating/communicating with the Compound Information Specialists on compound level metadata definitions;

  • ensuring compliance with compound level metadata definition; and

  • ensuring realization and maintenance of compound level analysis data structures with input as necessary from other CI&A/GDS&A functions.

Who you are

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

  • bachelor’s degree (or foreign equivalent degree) in Mathematics, Computer Science, Natural Sciences, Informatics, Electronics or a related field;

  • five (5) years of post-baccalaureate and progressively responsible experience in a related position;

  • setting up, updating, and maintaining the cleanliness of the study databases;

  • cooperating with Research Group, including cross-functional initiatives across multiple departments;

  • performing clinical data analysis and clinical data migration, integration of various studies, preparation of analysis datasets, tables, listings, graphs, SDTM, ADaM, QC/validation and documentation according to the Standard Operating Procedures (SOPs), Statistical Analysis Plans (SAPs) and departmental guidelines;

  • FDA submissions and other regulatory agencies including NDA, ISS;

  • writing and validating SDTM mapping specifications and ADaM specifications as well as creating code lists for mapping purpose;

  • reviewing SAP and annotated CRF and creating table shells for adhoc requests;

  • providing programming support for unblinding activities, data cuts, DMC’s, Blinded data reviews and Annual submissions;

  • leading initiatives to improve quality, efficiency or adherence to standards, including cross-functional initiatives across multiple departments;

  • Base SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and SAS/ODS;

  • Hash Objects in SAS, and using Perl Regular Expressions (PRX) in Programming;

  • using Windows PC-SAS, Unix SAS, SAS Enterprise Guide, Macumba and Tosca; and

  • pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11).

Experience can be concurrent.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country:United States

Location:NJ-Whippany

Functional Area:[sapfa28]

Entry Level:5

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