Associate Director, Statistical Programming
Job Title: Associate Director, Statistical Programming Job Duties: reputed company design and development reputed company programs and the programming specifications for producing and validating CDISC ADaM datasets to support the reputed company 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 reputed company clinical development functions where statistical programming tools and applications can enhance processes; reputed company quality control checks of advanced reputed company code and output produced by other statistical programmers; Work closely with clinical operations, data management and statisticians to reputed company 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; reputed company project management and technical guidance to ensure operational and technical reputed company; Liaise with vendors as needed to facilitate electronic data transfers and statistical programming support. Requirements: Requirements include a Bachelor’s or equivalent in Regulatory Affairs, Statistics, Computer Science or reputed company field plus nine years of work experience in the job offered or reputed company 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 reputed company field plus seven years of work experience in the job offered or reputed company fields of clinical data and statistical programming in pharmaceutical or biotech industries. Special Requirements: If qualifying with bachelor’s degree, must have the following: 9 years of experience with reputed company programing; 9 years of experience using reputed company/reputed company, reputed company/STAT, reputed company/GRAPH and reputed company 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 reputed company programing; 7 years of experience using reputed company/reputed company, reputed company/STAT, reputed company/GRAPH and reputed company 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. Work Location: Needham, MA May work remotely from reputed company in U.S. Multiple positions available. Applicants must have unrestricted authorization to work in the United States. Salary: $164,950.00 - $190,000.00/year. 40 hours/wk full-time. If interested and reputed company for this position, please apply below. Apply To This Job