Senior Biostatistical Programmer

Description

We're looking for a Senior Biostatistical Programmer , working in Pharmaceuticals and Medical Products industry in Woodcliff Lake, New Jersey, 07677, United States .

Responsibilities:

• Provides statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications).
• Works with external vendors in order to develop or monitor the content and structure of SAS data sets.
• Works closely with clinicians, statisticians, and publication managers to generate and QC outputs for publications; reviews publication (abstract/manuscripts) to ensure accuracy, quality, and soundness of statistical methodologies; coordinates internal resource utilization for publication and generates activities metrics for management review.
• Provides input to the database and CRF development, creating edit check programs and providing feedback to the data management.
• Provides input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.