Clinical Data Programmer, Elluminate Specialist
iSoftTek Solutions Inc
SQL
Programmer
Iovance Biotherapeutics, Inc.
contract
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
SQL
About the role
- Oversee the work of direct reports to ensure on-time, on-target and within-budget results.
- Maintain communication with data management and clinical operations.
- Exercise independent judgment in developing methods, techniques and evaluation criteria.
- Design, develop, evaluate and modify computer programs to analyze and evaluate clinical data.
- Oversee and manage workflow for study-specific and ad-hoc clinical data listings, summary tables and figures.
- Determine methods and procedures on new assignments.
- Perform data analysis primarily using SAS for summary and interpretation of clinical trial data.
- Manage creation of CDISC SDTM and ADaM files, SAS export files, and Define.xml for electronic submission.
- Manage data analysis and statistical analysis; generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Review Data Management Plan, Data validation plan and edit check specifications.
- Interact with statisticians and clinical team; perform ad hoc analysis and generate outputs per requirements.
- Implement and contribute to statistical analysis plans; provide expertise related to protocol development, CRF design and data collection.
- Identify and initiate resolution of data inconsistencies and quality issues.
- Manage development of SAS coding and table templates; create tools to improve programming efficiency and quality.
- Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
- Adhere to company core values, policies, procedures, business ethics and safety SOPs; perform miscellaneous duties as assigned.
Requirements
- MS or higher degree in Statistics, Math or Scientific Discipline.
- 5-8 years Pharmaceutical/Biotech programming experience.
- Strong SAS programming and Statistical background; experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
- Prior management/supervisory experience.
- Ability to use professional concepts to achieve objectives in creative and effective ways.
- Experience in the analysis of complex Oncology clinical trial data.
- Experience managing multiple projects.
- Solid knowledge of SAS Programming language.
- Experience creating CDISC SDTM and ADaM files, SAS export files, and Define.xml for electronic submission.
- Experience generating safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Experience implementing and contributing to statistical analysis plans.
- Ability to review Data Management Plan, Data validation plan and edit check specifications.
- NDA or BLA submission experience (preferred).
