FierceBiotech and FiercePharma Jobs
Senior Data Management Programmer - Bayer HealthCare Pharmaceuticals
Oct 01
Location: Montville, NJCategories: Pharmaceutical
Website: http://www.bayerjobs.com.
Position Description
At Bayer HealthCare Pharmaceuticals we take pride in knowing that our work is an affirmation of life. It stems from our commitment to advance patient care and to shape the future of medicine. It also connects us to the many lives we serve in the Women’s Healthcare, Oncology, Diagnostic Imaging, and Neurology markets. We are a global research-based pharmaceutical company and our purpose is to bring diagnostic and therapeutic innovations to the healthcare community. With a vast global network and a robust product pipeline and U.S. revenues exceeding $2.6 billion, we offer the opportunity for career fulfillment and the chance to make life the best it can be.
Design and programming of clinical data structures for assigned drug development projects and studies. Support and ensure the preparation, transfer and integration of clinical data from internal and external sources into the BSP organization. Provide data in various formats and applications to data management customers. Ensure high quality deliverables and active participation in teams.
Setup of the clinical study database in close cooperation with the EDC database developer and data manager.
Setup of Data Management tools for study conduct (e.g. edit checks, validity tool, coding call, SAE etc.)
Full study programming and validation support
Develop programs for transformation of the acquisition data from the EDC system \ data management system to the Operational Acquisition Database (OAD) to meet BSP project standards.
Ensure in conjunction with (project) data manager adherence to BSP standards and validation of all study related calculations and data mappings.
Responsibility for data exchange with external parties, for example, CROs, external data providers (Labs, ECG, etc) and Data Monitoring Committees.
Provide ongoing day to day end-user support to the data managers to ensure all systems and programs are executing correct and efficiently.
Setup and support of medical review and reporting tools and listings used by customers in Data Management, Biostatistics, Global Drug Safety, Medical Affairs, Clinical Pharmacology, Regulatory Affairs and Study Management. Attend Study Team meetings, as requested, provide update on progress.
Bachelor’s degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation with at least 5 years related experience of which 3 + years are in the pharmaceutical industry and include 2 + years experience as a SAS programmer or data analyst in the pharmaceutical industry. Good understanding of the drug development process. Very good understanding of data handling processes and preferable clinical study programming. Effective self-management and organizational skills. Basic negotiation and issue management skills. Significant experience in SAS programming and/or using data management technologies (e.g. clinical data management systems, electronic data capture, data review tools, data warehousing)
Good understanding of regulations, standards and guidelines (e.g. ICH, GxP, CDISC, European Clinical Trials Directive, Privacy rules [HIPPA]) Ability to manage regional teams and resources. Fluency in English plus the local language is required
Good written and oral communication skills in local language and English. Relevant experience can substitute degree requirements.
