Senior/Principal Statistical Programmer

Gaithersburg, MD 20697

Posted: 02/13/2019 Category: Pharmaceutical Job Number: 281197-29_1
Smith Hanley Associates
Senior/Principal Statistical Programmer
Washington DC area
Nihar Parikh - [email protected]

In this role you will provide statistical programming support for drug products including analysis and reporting, clinical studies, regulatory submissions, commercialization, and technical standards.

-Oversee quality of deliverables and support clinical development plans, regulatory submissions, data reporting, and Oncology projects.
-Deliver clinical study reports, SDTM/ADaM databases as well as tables, listings and figures results.
-Provide statistical programming for regulatory submissions.
-Manage technical database standards and programming specification documents.
-Develop best practices and monitor safety/efficacy of the data.

-Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline.
-5+ years' experience in the pharmaceutical/biotech industry required. Background in Oncology, Respiratory, Cardiovascular, or similar therapeutic area and strong project management.
-Experience in clinical drug development, regulatory requirements, CDISC standards, and data submission.
-Experience in statistical programming, report publishing, and the ability to define business processes.
-Strong SAS programming; Exposure to R, SQL, etc. a plus.

#GD 2019NP

Nihar Parikh
Executive Recruiter

Nihar manages recruiting in biostatistics and other clinical areas. He likes recruiting because it allows him to impact a company’s greatest asset, their employees.  

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