Statistical & Clinical Data Management Programmer II

Seattle Children's; Seattle (WA); On-site; USD 107,000 - 161,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision plans

403(b)

Life insurance

Paid time off

Tuition reimbursement

Job summary

Seattle Children’s is seeking a Statistical & Clinical Data Management Programmer II to support data programming and study builds for clinical studies. You will develop clinical study databases, review listings, and generate analytic datasets and TFLs for FDA/DSMB reporting while ensuring compliance with FDA, ICH, and CDISC standards.

Strong SAS/R experience is required. The role includes collaboration with biostatisticians, data managers, and external stakeholders, plus contributing to SOPs and

Qualifications

• Bachelor's Degree in a scientific discipline or related field.
• Minimum of three (3) years programming experience, including one (1) year programming in SAS.

Responsibilities

• Provide database and statistical programming support for department’s clinical studies.
• Design, implement, quality control and document programs and database applications.
• Coordinate programming operations with statistical methodologies and packages.
• 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 alignment with project goals.

Skills

SAS

R

EDC systems

Data management

FDA/ICH/CDISC knowledge

Education

Bachelor's degree in a scientific discipline

Tools

MediData Rave

MS Access

Advarra

Job description

***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.

About Us

Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE

Our founding promise to the community is as valid today as it was over a century ago: we will care for all children in our region, regardless of the families’ ability to pay. Together, we deliver superior patient care, advance new discoveries and treatments through pediatric research, and serve as the pediatric and adolescent, academic medical center for Washington, Alaska, Montana and Idaho – the largest region of any children’s hospital in the country.
U.S. News & World Report consistently ranks Seattle Children’s among the nation’s best children’s hospitals. For more than a decade, Seattle Children’s has been nationally recognized in key specialty areas. We are honored to be one of the nation’s very best places to care for children and the top-ranked pediatric hospital in Washington and the Pacific Northwest.

As a Magnet designated institution, we recognize the importance of hiring and developing great talent to provide best-in-class care to the patients and families we serve. Our organizational DNA takes form in our core values: Compassion, Excellence, Integrity, Collaboration, Equity and Innovation. Whether it’s delivering frontline care to our patients in a kind and caring manner, practicing the highest standards of quality and safety, or being relentlessly curious as we work towards eradicating childhood diseases, these values are the fabric of our culture and community. The future starts here.

Our Commitment

Seattle Children’s welcomes people of all experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our patients and families. Our organization recruits, employs, trains, compensates, and promotes based on merit without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

The people who work at Seattle Children’s are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves.

Seattle Children’s is proud to be an Equal Opportunity Workplace and Affir­mentative Action Employer.