Statistical Programming - AD/Director
Gaithersburg, MD 20697
Statistical Programming - Associate Director/Director
Washington DC area
Nihar Parikh - [email protected]
In this role you will lead programming projects, support regulatory submissions, clinical development plans, technical data standards and reporting within Oncology, Diabetes or similar area. Seeking experienced programmers with attention to detail and ability to manage multiple projects.
-Provide statistical programming expertise, regulatory submissions, and manage the clinical development process
-Manage direct reports and implement CSR development as well as statistical methodologies
-SDTM and ADaM datasets, technical expertise and quality of deliverables
-Information infrastructure, safety and efficacy of the data, quality improvements
-Seeking candidates with a degree in Biostatistics, Applied Mathematics, Engineering, Life Sciences or related fields.
-Extensive SAS programming and pharmaceutical experience required
-Experience in Oncology, Diabetes or similar therapeutic area
-Experience in CDISC standards, regulatory submissions, and clinical drug development
-Advanced problem solving and ability to lead/mentor teams
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