Director, Statistical Programming

Coordinates delivery of PV outputs to Drug Safety to support timely Safety review Ensures team compliance with SOPs and departmental standards; At least 12 years' industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent; At least 3 years as a people manager, including authorship of performance evaluations Significant experience leading programming teams in support of clinical development compounds to report the results of clinical trials, integrate analyses across a program, and prepare data/analysis for electronic NDA or BLA submission; Expert at the creation of technical programming specifications, standards and producing complex, validated SAS/R programs; Demonstrated experience in leading teams to implement submission-ready CDISC standards, including SDTM, and ADaM, Data Reviewer guides, and Define xml for multiple studies across a compound and for regulatory submission; Excellent collaboration and partnership skills with cross-functional peers in Clinical Operations, Regulatory, Medical Writing, Safety, Clinicians, Medical Affairs, etc. and/or vendor relationships; Expert 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 independently developing processes/SOPs, Standards or implementing programming best practices; Experience leading and maintaining positive vendor relationships in support of a compound/program in the delivery of quality programming support; Excellent written and oral communication, planning and organizational skills required; Expert problem-solving and decision-making skills with respect to best practices for Programming, and compound, data or submission strategies Experience leading statistical programming process or technology improvement projects through to implementation Bachelor's Degree required, Master's Degree Preferred, in areas of computer science, statistics, mathematics or information sciences. Clear alignment with Alnylam Core Values