Strategic Statistical Programmer Leader

3 days ago

ajmer, India beBeeStatistical Full time

Job OpportunityWe are seeking an experienced and skilled statistical programmer to lead programming activities for clinical studies. The ideal candidate will have a strong background in statistical programming, excellent communication skills, and the ability to work independently.The successful candidate will be responsible for implementing and executing programming standards to support ongoing clinical studies and requests for study reports, regulatory submissions, and ad hoc/post hoc analysis.They will work closely with internal stakeholders and external functional service providers to ensure timely and high-quality deliverables.The individual will participate in the development of standard macros, libraries, and processes, and contribute to team-based programming tasks.Key Responsibilities:Lead statistical programming activities for multiple studies/projects across various therapeutic areas or compounds/indications.Develop and maintain programming documentation following established standards and processes.Oversee the development of SAS programs for creating SDTM and ADaM datasets according to CDISC standards and reports (Tables, Listings, and Figures).Contribute to establishing and maintaining statistical programming standards, and participate in CRF annotation, review of SAP, TLFs specifications development, and TLFs review.Manage P21 related items, including eCRT packages, aCRF, define.XML, cSDRG, ADRG, and ARM, for regulatory submissions to FDA/EMA/PMDA or other agencies.Support global regulatory authority submissions following guidelines (sdTCG, DSC, eCTD etc.) and collaborate with partnering functions to address health authority requests.Exhibit company values by demonstrating 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 SME, focusing on quality and meeting regulatory submission requirements.Ensure all work is completed according to internal SOPs where applicable.Mentor and coach new hires and junior programmers, requiring good collaborative skills.

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