Senior Manager, Statistical Programming

Job Description
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 support
Develop and validate programming specification for table, listing, and figure
Develop and validate SAS program that generate table, listing, and figure
Apply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF, SDTM mapping specification and ADaM specification
Develop and validate SAS program that generate SDTM and ADaM dataset
Create and validate files necessary to support electronic submission in eCTD format
Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publication
Support development of CRF, edit check, review of Data Transfer Specification, and any other collaborations with Data Management function