What You'll Do

The Principal Clinical Database Systems Programmer will be responsible for performing SAS or SQL data programming to execute the design, build, and maintenance of clinical data collection systems. This includes developing customized, programmed data listings and data reports/visualizations, and/or EDC study database builds. The Principal Clinical Programmer will manage the study-defined specifications and requirements to lead clinical programming activities across one or more studies for the DM Operations and Clinical Development functional areas and liaise with our biostatisticians to understand final requirements and structure of study data/database design being presented.

Responsibilities

• Creates standard and/or custom programs/reports using data analytics tools such as SAS, Tableau, or other data visualization tools to support data oversight and review by data managers or other data reviewers.
• Leads EDC database build programming, testing, and migration of CRFs and edit checks or dynamics (database specifications, etc.) using EDC platforms (e.g. Veeva Vault, Medidata Rave).
• Collaborates with clients, peers, programmers, project teams, and/or requestors to clarify and finalize data specifications; uses expanded technical skills to meet evolving project needs.
• Supports the development, delivery and maintenance of clinical data review standards, tools and systems, across various data sources (e.g., clinical data, safety and operational data).
• Supports initiatives for Data Management and Clinical Programming for clinical data review bridging and database development activities, meetings, discussions.
• Assists in the management of electronic data from external data sources/vendors in partnership with the Data Management Lead for import or integration to clinical database tools. Liaises with vendors as needed to facilitate electronic data transfers and/or data specification requirements.
• Assists in review and approval of required study documentation, including design specifications, user requirements, data transfer specifications and data standards.
• Provides leadership, training, guidance, and support to other department members on data review tools and clinical database development.

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office. There is

Who You Are

• Bachelor’s degree (or equivalent) in Science and/or Computer Systems/IT background
• Minimum 5-7 year experience in a pharmaceutical/biotech setting
• Advanced technical expertise in databases, EDC platforms (e.g. Medidata Rave, Veeva), data imports/integrations and data visualization tools (e.g. Tableau, Spotfire) and Python programming language is a plus
• Advanced programming and analytical skills using SQL, BASE/SAS, SAS/STAT, SAS MACROS
• Ability to work independently to create standard datasets, program edit checks and produce quality data review outputs
• Demonstrated understanding of CDISC and SDTM requirements and implementation guidelines, able to create and validate CDISC standard datasets
• Knowledge of ICH GCP and Good Clinical Data Management guidelines

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