Director/Senior Director, Statistical Programming

Gaithersburg, MD 20697

Posted: 05/20/2019 Category: Pharmaceutical Job Number: 281188-37_1
Smith Hanley Associates
Director/Senior Director, Statistical Programming
Washington DC area
Nihar Parikh - [email protected]

Exciting leadership opportunity to join a global biopharma and oversee a team with statistical programming, regulatory submissions, data standards, clinical drug development, and foster decision making. Serve as core member of the programming leadership team.

-Manage a therapeutic area and direct programming projects.
-Oversee quality of deliverables and lead clinical development plans, regulatory submissions, and data collection.
-Manage clinical development programming, analysis and reporting, as well as information infrastructure.
-Implement best practices, develop strategies, and improve statistical methodologies within drug projects.
-Duties include standards development and technical guidance to meet business objectives.

-Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline.
-Proven leader in the pharmaceutical or biotech field and experience in statistical programming within clinical drug development.
-Strong knowledge of CDISC standards such as CDASH, SDTM, ADaM, etc.
-Strong SAS expertise and a background in Oncology, Respiratory, Inflammation or similar therapeutic area.
-Experience in NDA/BLA regulatory submissions and good clinical practice.
-Strong technical knowledge and people management background.

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


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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