Statistical Analyst - (ADaM / TLF) Hybrid

Role Summary

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. This is a hybrid position (3 days a week on-site/2 days remote). Candidates must be local and work hybrid out of San Francisco, CA; Irvine, CA; Lake County, IL; Florham Park, NJ.

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
• 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. Validation of Tables, Listings and Figures.
• Create specifications for the structure of ADaM data sets for individual studies and integrated data

Qualifications

• 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.
• Demonstrated practical understanding of SAS programming or NONMEM concepts and techniques related to drug development.
• Basic understanding of CDISC Standards.
• Basic understanding of the drug development process.
• Ability to communicate clearly both oral and written.

Education

• 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.