Manager -sdtm Programming - Gurgaon, Haryana - Sun Pharmaceutical Industries

Description

**Job Summary**

This is a comprehensive role that requires expertise in programming to lead and support all programming activities. The successful candidate will work independently, implementing and executing programming standards to support ongoing clinical studies, regulatory submissions, and ad hoc post hoc analysis.

The incumbent will work closely with internal stakeholders and external functional service providers to ensure timely and high-quality programming deliverables. They will participate in department goals, SOPs, macros, SME topics, and act as a technical expert providing guidelines on complex programming tasks and standards.

In this role, you may lead statistical programming activities for a therapeutic area or compound indication within multiple studies, projects, and various study activities. You will develop and maintain programming documentations following programming standards and processes, create CDISC standard SDTM mapping specifications and ADaM specifications, and develop SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports.

You will contribute to the development of standard macros, participate in establishing and maintaining statistical programming standards, and participate in CRF annotation, review of SAP, TLFs specifications development, and TLFs review. Additionally, you will handle 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.

This role requires proficiency in SAS programming skills in a clinical data environment with excellent analytical skills, working knowledge of other programming languages such as R, Python, great knowledge of pharmaceutical clinical development, and regulatory submissions. You should be able to work independently and on global interdisciplinary teams, have good organizational, interpersonal, and communication skills, and demonstrate problem-solving and innovative skills that show initiative and motivation.

To be considered for this opportunity, you must have a minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related discipline with 8 years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO, or healthcare-related industry.