BD (Becton, Dickinson and Company) Principal Clinical Database Programmer in Franklin Lakes, New Jersey
Job Description Summary
The 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.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Duties and Responsibilities:
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 direction 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.
For many roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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 Location
USA NJ - Franklin Lakes