Senior/Principal Statistical Programmer

Gaithersburg, MD 20697

Posted: 03/11/2019 Category: Pharmaceutical Job Number: 281197-32_1
Smith Hanley Associates
Senior/Principal Statistical Programmer
Washington DC area
Nihar Parikh - np[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.

Responsibilities:
-Oversee quality of deliverables and support clinical development plans, regulatory submissions, data reporting, and more.
-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.

Qualifications:
-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.
-Experience in clinical drug development, regulatory requirements, CDISC standards, and submissions.
-Experience in statistical programming, report publishing, and business processes.
-Strong SAS programming; Exposure to R, SQL, etc. a plus.
-Strong technical and project management skills as well as the ability to influence stakeholders.

www.smithhanley.com

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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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