Manager 1, Statistical Programming

About the role

The Manager 1 will provide comprehensive programming expertise to lead and support all programming activities as per the project strategies. The incumbent should be able to work independently implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.

What you'll do

• Lead statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects in various study activities to ensure timely and…
• 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

What you need

• 10–18 years in software engineering
• SAS
• SOP writing
• VBA
• Regulatory affairs
• SAP
• B.Tech or B.E. or B.Sc or BCA

Good to have

• Python
• R