Visionary Statistical Programmer

5 days ago

ballari, India beBeeStatistical Full time

Lead Statistical Programmer RoleThis position is responsible for overseeing statistical programming activities within various studies and projects across multiple therapeutic areas or compounds/indications.About the RoleThe successful candidate will be responsible for implementing and executing programming standards to support ongoing clinical studies, regulatory submissions, and ad hoc/post hoc analysis. Key responsibilities include developing and maintaining programming documentation, creating CDISC standard SDTM mapping specifications, and overseeing the development of SAS programs for dataset creation following CDISC standards.Key Responsibilities:Statistical Programming Leadership: Lead statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects in various study activities.Programming Documentation: Develop and maintain programming documentations following programming standards and processes.CDISC Standards: Create CDISC standard SDTM mapping specifications and ADaM specifications.SAS Program Development: Develop and oversee the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports.Maintenance and Enhancement: Contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards.Collaboration and Support: 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 to global health authorities.RequirementsStrong Statistical Knowledge: In-depth understanding of statistical concepts and principles, as well as experience with statistical software such as SAS.Programming Skills: Proficiency in programming languages, particularly SAS, and ability to write efficient and effective code.Communication and Collaboration: Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.

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