Statistical Analyst - ADaM Programming (Hybrid)

The Statistical Analyst is an integral role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data without supervision for routine activities and with supervision for more complex activities. The Statistical Analyst interfaces with Statistics, Clinical Data Strategy & Operations and Development Operations.

Responsibilities

Leads the statistical programming activities for routine studies; Create documentation for regulatory filings including reviewers guides and data definition documents; Participate in the development of standard SAS Macros, as well as presenting information on existing Macros; Produce dynamic and static data visualizations to communicate quantitative analyses; Develop SAS programs for the creation of ADaM data sets following CDISC standards; Develop SAS programs for the creation of Tables, Listings and Figures; Validation of ADaM data sets and Tables, Listings and Figures; Create specifications for the structure of ADaM data sets for individual studies and integrated data

Requirements

MS in Statistics, Computer Science or a related field with 2+ years of relevant experience, OR BS in Statistics, Computer Science or a related field with 4+ years of relevant experience; Experience in pharmaceutical clinical trials; Demonstrated practical understanding of SAS programming related to drug development; Experience creating and reviewing ADaM datasets for analysis; Ability to communicate clearly both oral and written; Basic understanding of CDISC Standards; Basic understanding of the drug development process

Nice to have

Demonstrated ability to support efficacy analyses across clinical development phases and therapeutic areas

Benefits

Comprehensive package of benefits including paid time off (vacation, holidays, sick); Medical, dental and vision insurance; 401(k) for eligible employees; Eligibility to participate in short-term incentive programs