1093#Senior Statistical Programmer, Early Stage Development and PK/PD Modeling and Simulation Consultant (Hybrid at PA/NJ)
ClinChoice
SDLC
Manager, Statistical Programming
Gilead Sciences
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $133,195 - $172,370 per year
Job Level
Mid-LevelSenior
About the role
- Serves as a project lead to provide oversight on multiple outsourced aggregated product level safety analyses projects.
- Acts as a fluent programmer in sophisticated Clinical Safety Surveillance analyses projects.
- Independently identifies issues in the analysis and assures project quality consistency.
- Acts as a stakeholder in multi-functional discussion on project scope, milestone, and project timeline negotiation.
- Lead programmer for multiple projects; may serve as project leader; overseeing vendor project activities and deliverables.
- Generates or oversees the production of statistical output for aggregated compound level safety projects.
- Actively share experiences and discuss possible process enhancements at programming meetings; recommends potential trainings.
- Ensures programming and documentation is completed in a manner that is consistent with departmental procedures; must lead and manage multiple concurrent projects.
- Knowledge of CDISC Standards (SDTM and ADaM) is a plus.
- Understands KPI/KQI, data harmonization, and analysis dataset creation for safety deliverables.
Requirements
- 6 years of experience and a BS degree in Biostatistics/Computer Science or equivalent
- OR 4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent
- Experience using SAS macros to automate deliverables
- Knowledge of CDISC SDTM/ADaM and clinical trials design and reporting
