Associate Director/Director, Statistical Programming

Gaithersburg, MD 20697

Posted: 05/09/2019 Category: Pharmaceutical Job Number: 281401-25_1
Smith Hanley Associates
Associate Director/Director, Statistical Programming
Washington DC area
Nihar Parikh - [email protected]

Our client, a global biopharma, has leadership openings in statistical programming. In this role you will lead programming projects, clinical development plans, technical data standards, regulatory questions, delivery of databases and reporting.

Responsibilities:
-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.

Qualifications:
-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.

Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.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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