Principal Clinical Database Systems Programmer

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 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; 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, and liaises with vendors as needed; 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

Requirements

Bachelor's degree (or equivalent) in Science and/or Computer Systems/IT background; Minimum 5-7 year experience in a pharmaceutical/biotech setting; 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

Nice to have

Advanced technical expertise in databases, EDC platforms (e.g. Medidata Rave, Veeva), data imports/integrations and data visualization tools (e.g. Tableau, Spotfire); Python programming language

Benefits

Market-leading compensation; 401(k) with employer match; Employee Stock Purchase Program (ESPP); Pre-tax commuter benefits (transit and parking); Referral bonus for hired candidates; Subsidized lunch and parking on in-office days; 100% employer-paid medical, dental, and vision premiums for you and your dependents; Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA); Fertility & family-forming benefits; Expanded mental health support (therapy and coaching resources); Hybrid work model with flexibility; Flexible, take-what-you-need paid time off and company-paid holidays; Comprehensive paid medical and parental leave; Career pathing, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching; Performance financial rewards, peer-to-peer recognition, and growth opportunities