Statistical Programming - AD/Director
Gaithersburg, MD 20697
Statistical Programming - Associate Director/Director level
Washington DC area
Nihar Parikh - npar[email protected]
In this role you will lead programming projects, clinical development plans, technical data standards, regulatory questions, delivery of databases and reporting.
-You will be the programming leader at the drug project level. Support the clinical development process, project strategy, regulatory submissions, commercialization of company drug products and information deliverables.
-Provide technical expertise, delivery of SDTM and ADaM datasets, as well as quality of deliverables.
-Oversee information infrastructure and quality improvements to the methodology.
-Contribute to best practices for statistical programming globally.
-Seeking candidates with a degree in Biostatistics, Applied Mathematics, Engineering, Life Sciences or related fields.
-Extensive SAS programming and pharmaceutical experience required.
-Experience in therapeutic areas such as Oncology, Diabetes or Diseases.
-Experience in CDISC standards, regulatory submissions, and clinical drug development.
-Advanced problem solving and ability to lead/mentor teams.
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