Katalyst Healthcares and Life Sciences
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 dat
- 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
- 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