Project Data Analyst II

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Boehringer Ingelheim is a family-owned company that is in the business of providing our customers with pharmaceutical and animal health products that significantly enhance their health and improve their quality of life. Our most important resource is our committed, creative and determined employees whose energy is focused on discovery, development and delivery of our innovative products to those who need them. The employees of Boehringer Ingelheim are our most important competitive advantage. Our global presence and thinking provides the opportunity for employees to work internationally and on teams, offering them visibility and the ability to influence the direction and outcome of critical projects. Competitive benefit and compensation programs reflect the Company's high regard for its employees and enhance each person's ability to balance the demands of work and personal responsibilities. Every employee at Boehringer Ingelheim contributes to the company's uncompromising commitment to quality in our products, excellence in our scientific pursuits and high ethical standards of behavior. The diversity of our employees makes it possible for us to craft unique solutions to today's complex business challenges. We are an equal opportunity employer. M/F/D/V.

Job Description
REQUIREMENTS:

* Bachelor's degree in Statistics, or Computer Sciences with a minimum of 3 years experience in the Pharmaceutical Industry with responsibilities directly related to Clinical Drug Development.

* Excellent data organization and presentation skills.

* Proficient in SAS, PC-based applications software, database structure and design.

* Excellent understanding of structured coding techniques, documentation principles, and validation principles.

* Familiarity with regulatory guidelines for NDA submissions and with technology trends relevant to clinical drug development.

* Excellent problem solving skills and communication skills.

DUTIES AND RESPONSIBILITIES:

* Assist in the establishment of standardized data displays and standard edit checks to support clinical trial integrated reports, INDs, PLAs, NDAs and DIRs.

* Responsible for proper coding documentation and validation of programs/macros/procedures to produce the standardized data displays. Establish and maintain validated project databases.

* Established and maintain libraries of fully documented and validated applications/ programs/macros/procedures which are used and recycled whenever possible to support the monitoring and reporting of data from clinical trials.

* Assist in the establishment of guidelines and standard operating procedures for the coding, documentation, and validation of programs/macros/procedures which support the monitoring and reporting of clinical trial data.

* Ensure proper and consistent implementation and maintenance of guidelines and standards within the data management group.

* Analyze requests for application programming support and translate user requirements into a structured diagram. Work with other departments to create fully documented, validated applications which can be used by the requester and others to satisfy their needs.

* Work with vendors, contractors, and other OPUs in establishing procedures for accessing and transferring data to and from their computers.