Lead design and development SAS programs and the 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.

Requirements include a 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 in the alternative, a 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.
If qualifying with bachelor’s degree, must have the following: 9 years of experience with SAS programing; 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; and 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 programing; 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; and 7 years of experience working in a clinical trial setting.

Associate Director, Statistical Programming

Key skills