Hiring for Principal Biostatistician Hyderabad for Exp. 8 - 12 Years at PAREXEL International (India) Pvt. Ltd..
MedWiz Hyderabad, Telangana, India
Feb 19, 2018Full time
Job Description:Provide statistical guidance, review, and contribution to SAPs TFL shells, DMC Charters, SDF specification (SDTM & ADaM), randomization specs, and other key-study related documentation, protocol deviations, data quality review, and other communications. Attend and be a contributor at Clinical Study Team meetings between 8-11 AM PT Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specification review, database development, IVRS spec review. Initiate cross-functional team meetings as necessary (e.g., analysis planning, TFL review) Complete statistical analysis of individual studies/projects Perform and document QC of primary and key secondary endpoints within ADaM datasets as well the statistical analyses of these endpoints (by programmatically) Perform data-driven modelling during clinical studies Create required outputs for DLRM (Dose Level Review Meeting) Review TFLs created by statistical programming for consistency and accuracy Author analysis reports such as Flash Memo, and results section of the CSRs Collaborate with the study programming team for study deliverables Manage timelines for all statistics-related deliverables for own projects and cross projects for other study statisticians Be familiar with all Companys policies, SOPs and other controlled documents related to study activities noted above Assist with study and systems audits conducted by Company GCA and external bodies