***Applicants must be currently authorized to work in the US on a full-time basis. Seattle Children's will not sponsor applicants for work visas for this 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.

Addendum to Statistical & Clinical Data Management Programmer II Role: SCTx

• 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.

Essential Functions:
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)

Required Education and Experience
Bachelors Degree in a scientific discipline or related field.
Minimum of three (3) years programming experience, including one (1) year programming in SAS.

Required Credentials
N/A.

Preferred

• Education: Bachelor's Degree in Statistics, Biostatistics, Epidemiology, Public Health, or a related field.
• Technical Experience: 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).
• Methodological Competency: Strong experience with statistical methodologies and statistical packages (SAS and/or R) to independently execute operational and reporting deliverables.

Compensation Range
$107,431.00 - $161,147.00 per year

Salary Information

This compensation range was calculated based on full-time employment (2080 hours worked per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided.

Disclaimer for Out of State Applicants

This compensation range is specific to Seattle, positions located outside of Seattle may be compensated differently depending on various factors

Benefits Information

Seattle Children's offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more. Additional details on our benefits can be found on our website www.seattlechildrens.org/careers/benefits.