The Senior Manager Statistical Programming will act as statistical programming lead for various clinical studies. You will collaborate with Biostatisticians and Statistical Programmers and ensure high quality and timely statistical programming deliverables. You also will perform oversight on the counterpart from vendors. You will report to Senior Director, Statistical Programming.You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and in-depth understanding of CDISC standards and drug development principles, preferably in solid tumor therapeutic area.Collaborate closely with Biostatistics, Data Management, Medical, Safety, Clinical Research, Clinical Operation, and other functions within Bicycle Therapeutics to address their needs for statistical programming supportDevelop and validate programming specification for table, listing, and figureDevelop and validate SAS program that generate table, listing, and figureApply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF, SDTM mapping specification and ADaM specificationDevelop and validate SAS program that generate SDTM and ADaM datasetCreate and validate files necessary to support electronic submission in eCTD formatConduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publicationSupport development of CRF, edit check, review of Data Transfer Specification, and any other collaborations with Data Management function
