Biostatistician II

Responsibilities Act as primary statistical contact for internal and external project team members. Communicate and work with Biostatistics management tomaintainthe project budget and timelines. Review case report forms (CRFs) and completion instructions Give input to database design and data edit considerations necessary to collect and clean data Develop, orassistin the development of, Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol Develop program specifications – SDTM andADaMdataset specifications and mock tables,listingsand figures (TLFs) – needed to perform the analysis defined in the IAP/SAP Perform the statistical analysis by independently programming derived datasets and TLFs andvalidatethe developer's corresponding programs per department SOPs Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications Assistin planning and designing clinical studies, including: randomizationandblindingproceduresdevelopment statistical methods section development in the protocol Develop,orassistin the developmentof,Randomization Plans and randomization programs or lists Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines Rely on instructions and Biostatistics SOPs to ensuretimely, standard, and quality deliverables to customers Maintainsaccuraterecords of all work performed andensureall relevantstatisticsdocuments are filed in the eTMF per the project-specific eTMF Plan Provide input to andparticipatein departmental meetings Qualifications 2 years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experience Master's degree in Biostatistics, Statistics, or related field CDISC SDTM andADaMdataset mapping experience Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities Experience providing ability to explain complex statistical concepts to other project team members BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication) Therapeutic experience in transplantation, autoimmunediseases, andkidney and liver disease #J-18808-Ljbffr