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Principal Clinical Data Integration Programmer

Allergan, Inc.

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Location: Bridgewater, NJ Posted Date: 4/24/2013 Position Type: Full time Job Code: 130379 Required Education: High school or equivalent

Description

About Allergan:
Founded in 1950, Allergan, Inc. (NYSE: AGN) is a global multi-specialty health care company headquartered in Southern California with rapidly growing annual revenues of $5+ billion.  The company’s two primary segments are specialty pharmaceuticals and medical devices. Allergan's flagship franchises in eye care, neurosciences, medical dermatology and urologics, structured under Allergan Pharmaceuticals, offer specialty physicians and their patients a wide range of treatments to help preserve and protect sight, reduce physical disability and enhance quality of life.  In 2006, Allergan added aesthetics and dermal fillers to its business portfolio to create a world-leading medical aesthetics franchise. At the same time, Allergan added a leading product portfolio in obesity intervention that offers minimally invasive devices to help patients achieve sustained weight loss and reduce health risks associated with obesity.
   
About the Position:
The Principal Clinical Data Integration Programmer within Clinical Programming under the direction of management will lead the acquisition, transformation, integration, specification, validation, implementation, and ongoing support of clinical research and development data from multiple sources using ETL technologies (e.g., Informatica PowerCenter) and programs (e.g., SAS, PL/SQL) into target electronic systems (e.g., Clinical Data Repositories/Warehouses, Data Tabulation Datasets i.e., CDISC SDTM) used in Clinical Research and Development studies. Lead the development of clinical study design requirements against industry standards to deliver compliant datasets (e.g., CDISC SDTM). Support the implementation of electronic systems implemented internally or through external vendors according to regulatory requirements. Support clinical information delivery via dashboards and reports (e.g., Spotfire, Business Objects).

The employee is expected to be skilled in performing all the roles encompassed in the preceding grade levels within the job family as required by the organization.  Other activities, special projects and assignments may be given as required.  As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.

The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Principal Responsibilities:
Data Integration Programmer
Responsible for the role which includes acquisition, integration, and delivery of Clinical Study Data. Documentation and peer review of deliverables.

Clinical Programmer
Assist with the role which includes development, peer review and maintenance of database systems and tools to support Clinical Research activities. Provide leadership and content expertise for programming activities from startup through the statistical analysis stage of clinical studies in support of Global Development to effectively manage data capture, review and database lock activities.

AGN Personnel / Subject Matter Expert
Responsible for the role which includes participation in the identification, evaluation, recommendation, implementation and management of Clinical Information technology solutions to support Clinical study database activities including all forms of electronic data capture through in-house or third party vendors. Contribute to standardization of data capture, processing and reporting through traditional and innovative electronic solutions. Support Corrective Action and Preventive Action initiatives. Report process gaps and potential misconduct during clinical studies to management.

Requirements

Preferred candidates will have:
Degree in Computer Science, Life Science or related field: BS/BA degree with 6 years experience, or MS degree with 4 years experience.
Minimum 3 years experience within a clinical programming organization, preferably  within medium-large pharma or CRO.
Intermediate knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
Intermediate knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
Advanced knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
Intermediate knowledge of Research & Development and an understanding of regulatory guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)
Ability to effectively interact with and influence others without direct reporting relationships
Technical abilities and skills in analysis, design, specification and programming of computer systems
Analytical, problem solving and technical skills
Planning, organizational, and project management skills
Negotiation skills
Conflict management skills
Attention to detail with high quality outputs
Computer skills (word processing, spreadsheets, graphics, PowerPoint)
Competencies and skills in the following: cross functional relationships, communication, decision making,  execution/results/process improvement, customer satisfaction
Ability to travel 5%
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