Senior Statistical Programmer Lead

5 days ago

erode, India beBeeStatistical Full time

Job DescriptionWe are seeking an experienced Statistical Programmer to lead our programming activities. As a key member of our team, you will be responsible for implementing and executing programming and project standards.Work independently to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.Collaborate with internal stakeholders and external functional service providers to ensure timely delivery of high-quality programming deliverables.Main Responsibilities:Lead statistical programming activities across multiple studies/projects in various therapeutic areas to ensure timely and high-quality programming deliverables.Develop and maintain programming documentation following established standards and processes.Create CDISC standard SDTM mapping specifications and ADaM specifications.Develop and oversee the development of SAS programs for dataset creation and reporting following CDISC standards.Contribute to the development of standard and utility macros and participate in establishing statistical programming standards.Participate in CRF annotation, SAP review, TLFs specification development and review.Handle P21 related items and eCRT package submissions including aCRF, define.XML, cSDRG, ADRG and ARM for regulatory submissions.Support global regulatory authority submissions following guidelines and work closely with partnering functions to address health authority requests.Demonstrate company values by showcasing excellence, competence, collaboration, innovation, respect, ownership, teamwork and accountability.Understand project scope, plan and complete deliveries and timelines with the study team, programming lead and management.Perform end-to-end programming activities as a team player and subject matter expert.Focus on timelines and quality ensuring programming deliverables meet regulatory submission requirements.Ensure all work is completed adhering to internal SOPs where applicable.Mentor and coach new hires and junior programmers requiring good collaborative skills.

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