Senior Statistical Programmer

The Senior Statistical Programmer is responsible for providing leadership and hands-on support in the development and maintenance of the statistical programming capabilities which is required to meet regulatory obligations. The individual will work closely with the Associate Director, Director, and Statistical Programmers to build internal programming tools. This individual will be responsible for review datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. This individual will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.

Main Responsibilities and Accountabilities :

• Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content.
• Collaborates with study teams to ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
• Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and / or study statisticians as well as with clinical programming team and their collection of legacy data.
• Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
• Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
• Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.

Works closely with clinical study teams to plans and executes activities to ensure project timelines are met with high quality deliverables.

Additional tasks :

Position Qualifications and Experience Requirements :

Education

Experience

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