**Position has the ability to telecommute from anywhere in the United States within the following framework: must work onsite at company headquarters in Cambridge, MA one week per month and must be able to report to headquarters within 24 hours when requested for ad hoc situations.**
Responsible for handling statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. Responsibilities include the following: serve as a lead programmer and manage statistical programming efforts for multiple clinical studies; provide oversight of CRO statistical programming activities; manage the end-to-end programming of deliverables from CRF design through electronic submission including preparation of electronic submissions (ESUB) components; develop and review SDTM and ADaM specifications; develop and validate programs that generate SDTM, ADaM, tables, listings and figures; ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit; review critical clinical trial documents (e.g., Protocol, Statistical Analysis Plan, CRFs etc.) and provide constructive comments for improving individual documents and templates; act as an integral member of project team, including attending project team meetings and working with biostatisticians, data managers, clinical research managers and medical monitors, as appropriate; contribute to the development and implementation of standard programming practices and SOPs.
Must have MS in biostatistics, mathematics, computer/mechanical engineering, or a closely related field and 5 years of SAS programming experience in pharmaceutical industry that includes the following: providing statistical programming support to clinical trials; working with SAS programming, including SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro; supporting Biologic License Applications and Marketing Authorization Applications; working with FDA and ICH regulations and guidelines; working with CDISC standards; and handling multiple projects with aggressive timelines. Will also accept a BS and 7 years of experience in stated areas.