Global Lead Statistical Programming Professional

2 days ago


visakhapatnam, India beBeeStatistical Full time

Job Title: Global Lead Statistical ProgrammerLead statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects in various study activities to ensure timely and high-quality programming deliverables.Develop and maintain programming documentations following programming standards and processes.Develop and oversee the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports.Contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards.ResponsibilitiesLead statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects in various study activities to ensure timely and high-quality programming deliverables.Develop and maintain programming documentations following programming standards and processes. Create CDISC standard SDTM mapping specifications and ADaM specifications.Develop and oversee the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports (Tables, Listings and Figures).Contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards.Participate in CRF annotation, review of SAP, TLFs specifications development and TLFs review.Handle all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG, and ARM for regulatory submission.Support global regulatory authority submissions following guidelines and working closely with partnering functions to address health authority requests.Performing end-to-end programming activities, act as a team player, and SME.Focus on timelines and quality ensuring that programming deliverables meet regulatory submission requirements.Mentor and Coach new hires and junior programmers. Require good collaborative skills.



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