Statistical & Clinical Data Management Programmer II

Seattle Children's•Seattle, WA

5d•$107,431 - $161,147•Onsite

About The Position

Provide database and statistical programming support for department's clinical studies. Perform routine to complex programming responsibilities, including design, implementation, quality control and documentation of programs and database applications. Participate in unit infrastructure development. Support Data Programming and Study build: Support the development of clinical study databases, program data review listings, assist with CRF builds (MediData Rave, MS Access, or Advarra), generate analytic datasets and TFLs for FDA/DSMB reporting, and validation of study outputs. Analyze user requirements, assist with study builds, generate data dictionaries/variable specifications, and maintain user access requests on EDC databases. Serve as a key point of coordination for external partners, EDC vendors, and collaborators to ensure technical alignment on project goals. Track deliverables to ensure all external data structures comply with FDA, ICH guidelines, and CDISC standards (including SDTM and ADaM). Facilitate cross-functional communication across biostatisticians, data managers, and external clinical stakeholders. Coordinate programming operations using statistical methodologies and packages, participate in data management and analysis meetings, process initiatives, and assist with the preparation/review of unit Standard Operating Procedures and Work Instructions.

Requirements

Currently authorized to work in the US on a full-time basis.
Bachelors Degree in a scientific discipline or related field.
Minimum of three (3) years programming experience, including one (1) year programming in SAS.

Nice To Haves

Bachelor’s Degree in Statistics, Biostatistics, Epidemiology, Public Health, or a related field.
At least one (1) year of database programming experience using MediData Rave, MS Access, or Advarra, with a proven ability to comply with FDA and ICH guidelines (e.g., CDISC standards like SDTM and ADaM).
Strong experience with statistical methodologies and statistical packages (SAS and/or R) to independently execute operational and reporting deliverables.

Responsibilities

Work with study and unit teams to determine programming and database requirements for studies
Analyze user requirements, assist with study builds, generate data dictionaries and variable specifications; generate analytic datasets and tables, listings and figures (TFL) for FDA and DSMB reporting and analysis activities.
Assist with data and report validation using SAS and/or R.
Review protocol, case report forms, data management plan, data review plan, statistical analysis plan, and other study documents in order to anticipate and accommodate programming needs.
Maintain user access requests on EDC databases.
Participate in infrastructure planning meetings at the unit level; sit on teams for process and documentation initiatives
Participate in preparing and review unit Standard Operating Procedures (SOPs) and Work Instructions (WI's)