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 in 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 4+ years' experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph). In addition, must have at least three years of experience serving in a supervisory or lead capacity. Experience managing projects OR
Master's degree in computer science, mathematics, statistics, or related discipline and 1+ years of similar experience noted above OR
PhD in computer science, mathematics, statistics, or related discipline and 2+ years of similar experience noted above.
Demonstrates strong knowledge of 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.
Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas.
Proficient with tools and processes that support work conducted by functional area.
bility to work as part of a team; may train lower levels.