Advanced Clinical Programmer

3 days ago

udaipur, India beBeeProgrammingSpecialist Full time

Senior Statistical Programming LeaderKey Responsibilities:Implement and execute advanced programming standards to support ongoing clinical studies and requests for study reports, regulatory submissions, and ad hoc/post hoc analysis.Collaborate closely with internal stakeholders and external functional service providers to ensure all programming deliverables are delivered in a timely manner with high quality.Deliverables and Qualifications:Develop and maintain documentation following programming standards and processes. Create CDISC standard SDTM mapping specifications and ADaM specifications.Develop and oversee the development of SAS programs for 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 P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for regulatory submission to FDA/EMA/PMDA or other agencies.Support global regulatory authority submissions following guidelines and working closely with partnering functions to address health authority requests.Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, teamwork, and accountability.Understand scope of work, plan, and complete deliveries and timelines with study team, programming lead, and management.Perform 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.Ensure all work is completed adhering to internal SOPs where applicable.Mentor and Coach new hires and junior programmers.,

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