Principal Clinical Database Programmer
Job Description SummaryThe Principal Clinical Database Programmer (CDP) is an expert level programmer assigned to lead the development and maintenance of database builds in support of clinical studies. He / she will build study databases including development of database specifications/definitions, programming of CRF layouts, programming of validation and derivation procedures, and programming of various advanced reports to support the data review process. The Principal CDP will serve as a subject matter expert (SME) who will guide the CDP team and Clinical Data Managers (CDM) with new designs and updates in study conduct phase and will troubleshoot complicated technical issues as required for staff regarding specific database issues. He / She will drive process improvement initiatives to completion, and foster knowledge sharing and communication of best practices across all levels of the data management group.
- Serves as a subject matter expert (SME) in clinical database technology, capabilities and functionality.
- Develops database design specifications/definitions in consultation with data management, statistics and programming.
- Designs and creates clinical databases to enable data review/validation of the study data by Data Managers, and a comprehensive and efficient analysis by Statistics and SAS Programming.
- Programs and tests database configurations (edit checks, derivations, form/field dynamics, etc.).
- Programs and tests reports using SQL/SAS to identify inconsistencies and support data review efforts.
- Performs pre-processing and loading of non-CRF data files.
- Provides technical assistance and training to programming and non-programming personnel.
- Contributes to solutions for routine technical problems and liaises with IT as appropriate to resolve issues.
- Identify and implement solutions to data management issues and concerns that arise during the conduct of the study.
- Identifies and understands the need for standardization and takes initiative to help improve departmental efficiency.
- Establishes and maintains productive working relationships with all other functional areas that contribute to the execution of clinical studies.
- Develops solutions to basic problems and assists in the development of new technologies.
- Authors and/or contributes to Departmental SOPs, Business Guidance and/or Standards/Templates to define best practice and promote consistency.
- Maintains all required study documentation.
- Provides input into system validation efforts, loading of patches and change management.
- Advanced proficiency in one or more leading EDC systems.
- Expert level SQL scripting.
- Expert level understanding of relational databases.
- Experience in setting up the normalized datasets per SDTM.
- Knowledge of CDISC/CDASH.
- Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submissions.
- Ability to work independently with minimal supervision and manage multiple deliverables concurrently.
- Ability to ensure clinical database programming work is completed in a consistent manner and validated according to department practices.
- Excellent interpersonal skills, strong written and verbal communication skills.
- Working knowledge of clinical development.
- Working understanding of clinical trial principles and technical implications.
- Ability to interact effectively within and across team environment.
- Promotes knowledge sharing in the group.
- Provide leadership and mentorship.
- Ability to travel up to 10% of the time.
- Knowledge of SAS preferred.
- Experience with MedDRA and WHO dictionaries preferred.
Education and/or Experience:
- BA / BS computer science/information technology or life sciences from a 4-year accredited university.
- Minimum 6 years clinical database programming experience preferred in the device / pharmaceutical / CRO industry.
- An equivalent combination of education, industry related experience, and performance may be considered.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA NJ - Franklin Lakes
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