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Lead 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 in assigned projects and areas.
Develop and maintain programming documentations following programming standards and processes. Create 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 macros, participate in establishing and maintaining statistical programming standards.
Participate in the 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 the regulatory submission to FDA/EMA/PMDA or other agencies.
Support global regulatory authority submissions following the guidelines (sdTCG, DSC, eCTD etc.) and working closely with partnering functions to address health authority requests.
Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, team work and accountability.
Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management.
Participate and contribute towards department goals, SOPs, training guidelines and SME topics.
In a positive/collaborative environment, manage and mentor new hires and junior programmers.
Senior Manager 1, Statistical Programming
Gurgaon, INPosted 1 weeks ago