Job Description

Responsibilities:

Serves as the primary project team representative, delegating work as appropriate

Generates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains

Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials data

Reviews output across programs to ensure consistency

Reviews maintains and approves study documents per standard procedures

Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests

Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures

Provides technical expertise to the development of programming standards and procedures, technical expertise in the areas of analysis and reporting

Participates in the development and/or maintenance of departmental procedures and standards

Requirements:

BS/BA degree in computer science, mathematics, statistics, or related discipline and 5+ years' experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph). In addition, you must have at least three years of experience serving in a supervisory or lead capacity. Experience managing projects OR

Demonstrates strong knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines

Strong programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar

Strong knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains

Strong knowledge of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems

Strong understanding of relational databases and experience working with complex data systems

Understands key business drivers and uses this understanding to accomplish work

Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas

Job Tags

Permanent employment,

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