Statistical & Clinical Data Management Programmer II

Provide database and statistical programming support for departments 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 (WIs)

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: Bachelors 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

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.