Global Clinical Data Specialist

5 days ago

nellore, India beBeeStatistical Full time

OverviewThe Global Lead Statistical Programmer plays a pivotal role in our organization, overseeing the programming activities for Phase I-IV studies as per project strategies.Independently implementing and executing programming and project standards to support ongoing clinical studies and requests for study reports, regulatory submissions, and ad hoc/post hoc analysis.Closely collaborating with internal partnering functions, stakeholders, and external functional service providers to ensure timely delivery of high-quality programming deliverables.Participating in the development of standard macros, libraries, processes, and contributing to various programming tasks as a team player.About the RoleWe are seeking an exceptional individual with strong SAS programming skills in a clinical data environment, excellent analytical skills, and a working knowledge of other programming languages such as R, Python, etc. The ideal candidate will possess great knowledge of pharmaceutical clinical development, including statistical concepts, techniques, and clinical trial principles, as well as regulatory submissions (NDA, ANDA, etc.).Prior experience with PTL is highly desirable, along with attention to detail and the ability to adapt to a fast-paced environment.Able to work independently and on global interdisciplinary teams, possessing good organizational, interpersonal, and communication skills.Positive attitude, team player, and growth mindset, with problem-solving and innovative skills that demonstrate initiative and motivation.Key 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, creating 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 to FDA/EMA/PMDA or other agencies.Support global regulatory authority submissions following guidelines (sdTCG, DSC, eCTD, etc.) and work closely with partnering functions to address health authority requests.

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