Chief Statistical Programming Strategist

5 days ago

thiruvananthapuram, India beBeeLeadership Full time

Statistical Programming Leadership OpportunitySun-Pharma seeks a highly skilled Global Lead Statistical Programmer to lead programming activities for Phase I-IV studies as per project strategies. The ideal candidate will work independently implementing and executing programming standards to support ongoing clinical studies, regulatory submissions, and ad hoc/post hoc analysis.About the Role:This is an exceptional opportunity for a seasoned statistical programmer to lead multiple studies/projects within therapeutic areas or compounds/indications.The successful candidate will be responsible for developing and maintaining programming documentations following established standards and processes.We are seeking a team player who can contribute to the development of standard macros, libraries, and processes.A key part of this role involves CRF annotation, SAP review, TLFs specifications development, and TLFs review.The individual will handle all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG, and ARM for regulatory submissions.Responsibilities also include supporting global regulatory authority submissions following guidelines and collaborating with partnering functions to address health authority requests.In addition, we require our staff members to demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, teamwork, and accountability.

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