| Job Description | Applicants must meet the following requirements:
Bachelor’s/Masters Degree in Computer Sciences, Statistics, Mathematics or relevant scientific discipline
Bachelor’s Degree and 5 to 8 years experience, or Masters Degree and 2 to 5 years experience in SAS Programming. Four years experience in drug development.
Proven success in the development, documentation and qualification of programs to generate Tables, Listings and Figures for Clinical Studies, and in support of data cleaning activities.
Demonstrated experience in base SAS, SAS MACRO, SQL, Graph (or equivalent) and using ODS for presentations and data mining reports.
Demonstrated knowledge and understanding of programming standards and methodologies, GCP, ICH and related FDA regulations. Experience with the design and implementation of CDISC standard is a plus.
A background in statistics, having ability to assist in design of study analysis, and experience in designing and implementing a CDISC build are highly desired.
Experience with Oracle Clinical/RDC, Integrated Review, or other relational data management software is considered a plus.
Strong quantitative and analytical skills, with the ability to identify problems in complex algorithms and provide working solutions; must have a high level of attention to detail.
The selected candidate will be responsible for:
Developing, modifying, and maintaining an integrated and reusable programming suite, primarily in SAS, in support of the BDM department and clinical teams across multiple concurrent projects.
Designing and developing project-specific SAS programs for biostatisticians, producing validated analysis datasets, reports, and figures.
Development of utilities for QC/QA and analyses.
Developing listings and integrated computer programs to assist in the data review process and to provide operational metrics on resources and timelines.
Recognizing inconsistencies and initiating resolution of data problems.
Implementing data management plans designed to meet project and protocol deadlines, providing expertise in the design and development of clinical trials, protocols and case report forms.
Assisting in the design and creation of a cohesive, integrated programming environment capable of responding quickly to changing needs and being regulatory compliant.
Assisting in data retrieval from Oracle Clinical, vendors and other sources.
Recommending and participating in overall process improvements for programming.
Assisting in the development of guidelines and workflows for programming activities.
Acting as a liaison between project teams and subcommittees and the department. |
| | Company | | MacroGenics Inc. | Job Code | | State or Province | | Maryland | | |
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