Principal Statistical Programmer FSP

Sponsor-dedicated Principal Statistical Programmer working fully embedded within a pharmaceutical client to drive innovation in patient treatment. Requirements • Generate SDTM, ADaM specifications, datasets, reviewer s guide and define.xml files for multiple studies • Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs • Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs needs • Participate in overseeing CRO s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines • Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses • Understand and follow FDA regulations which affect the reporting of clinical trial data • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros • Participate in the development of CRFs, edit check specifications, and data validation plans • Provide review and/or author data transfer specifications for external vendor data • Collaborate with internal and external functions to ensure meeting project timelines and goals • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices Originally posted on Himalayas