Associate Director, Statistical Programming

Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions. Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of CDISC ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs. Works closely with Data Management on cross-functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs. Manages internal and vendor statistical programming support; Maintains strong collaboration and governance with preferred vendors. Performs, plans and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program. Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations). At least 10 years' industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent; Experience as a Programming manager (FTEs, Functional Service Providers or vendors); Experience leading programming teams in support of clinical trials to report the results of clinical trials, integrate analyses across a program, or prepare data/analysis for electronic NDA or BLA submission; Experience in constructing technical programming specifications and producing complex, validated SAS programs; Demonstrated experience in working with CDISC standards, including SDTM, and ADaM, and Define xml; Proficiency in understanding of statistical programming environments, processes, procedures, and roles; Excellent knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures; Preferred experience in R programming; Experience developing SOPs, Standards or implement programming best practices; Experience overseeing vendors in the delivery of quality programming support; Excellent written and oral communication and organizational skills required; Bachelor's Degree required, Master's Degree Preferred, in areas of computer science, statistics, mathematics or information sciences.