Associate Director, Statistical Programming

Role Description

• Lead design and development of SAS programs and programming specifications for producing and validating CDISC ADaM datasets to support the generation of tables, figures, and listings for clinical study report(s), FDA submission(s), and medical congress abstracts/posters/presentations.
• Responsible for internal statistical programming deliveries across multiple clinical studies, as well as implementing process improvements and department initiatives.
• Identify areas within clinical development functions where statistical programming tools and applications can enhance processes.
• Perform quality control checks of advanced SAS code and output produced by other statistical programmers.
• Work closely with clinical operations, data management, and statisticians to develop infrastructure for timely and quality reporting of clinical trials to support regulatory requirements and product launch activities.
• Proactively identify issues and recommend solutions to optimize preparation, execution, reporting, and documentation of statistical programming activities.
• Provide project management and technical guidance to ensure operational and technical excellence.
• Liaise with vendors as needed to facilitate electronic data transfers and statistical programming support.

Qualifications

• Bachelor’s or equivalent in Regulatory Affairs, Statistics, Computer Science, or related field plus nine years of work experience in the job offered or related fields of clinical data and statistical programming in pharmaceutical or biotech industries; or
• Master’s degree or equivalent in Regulatory Affairs, Statistics, Computer Science, or related field plus seven years of work experience in the job offered or related fields of clinical data and statistical programming in pharmaceutical or biotech industries.

Requirements

• If qualifying with bachelor’s degree, must have the following:
• 9 years of experience with SAS programming;
• 9 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH, and SAS MACROS;
• 7 years of experience with CDISC SDTM and ADaM;
• 7 years of experience with electronic FDA submission;
• 9 years of experience working in a clinical trial setting.
• If qualifying with Master’s degree, must have the following:
• 7 years of experience with SAS programming;
• 7 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH, and SAS MACROS;
• 5 years of experience with CDISC SDTM and ADaM;
• 5 years of experience with electronic FDA submission;
• 7 years of experience working in a clinical trial setting.

Benefits

• Salary: $164,950.00 - $190,000.00/year.
• 40 hours/week full-time.
• May work remotely from anywhere in U.S.
• Multiple positions available.
• Applicants must have unrestricted authorization to work in the United States.