Job Details

Overview

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Responsibilities

• Leads the statistical programming activities for projects with lower complexity.
• Leads the statistical programming activities for studies.
• 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, Tables, Listings and Figures.
• Create specifications for the structure of ADaM data sets for individual studies and integrated data.
• Create documentation for regulatory filings including reviewers guides and data definition documents.
• Lead the development of standard SAS Macros and participate in the development of standard operating procedures.
• Provide oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.

Requirements

• MS in Statistics, Computer Science or a related field with 6+ years of relevant experience, or BS with 8+ years of relevant experience.
• In-depth understanding of SAS programming concepts and techniques related to drug development.
• Fundamental understanding of CDISC Standards.
• Fundamental understanding of the drug development process, including experience with regulatory filings.
• Ability to communicate clearly both orally and in writing.
• Ability to accurately estimate effort required for study related programming activities.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing