About the Role

This is experienced level position and requires strong CDISC standard understanding and its implementation at dataset and various document level. You will be required to create robust SDTM & ADaM specification, review them methodologically and frequently end up taking technical decision on your own. The position is independent contributor level in which you will be mostly doing extensive programming to create and validate SDTM & ADaM datasets and generating TFLs. We are expecting someone who is independent in doing most of their on-job duty with minimal or no guidance, very proactive in raising questions/doubts and communicates with team clearly.

Qualifications

• At least 5 years of experience in Statistical programming field in either Sponsor or CRO side
• Undergraduate degree in Mathematics, Computer Science, statistics or any relevant healthcare faculty
• Extensive programming experience in SAS (and/or R, Python) preferably in a clinical trial environment
• Excellent written and verbal communication skills
• Ability to read, write, speak and understand English
• Basic understanding of clinical research domain

Responsibilities

• Create and validate SDTM & ADaM Datasets
• Create and review SDTM & ADaM specifications based on internal guidance and CDISC standard documents
• Create and review define.xml, reviewer’s guide and aCRF
• Create Table, listing and Figures, review and validate them
• Strong knowledge of SAS Programming and CDISC SDTM/ADaM understanding
• Follow all SoP and internal workflow to produce all deliverables
• Follow all Good programming practices to create machine executable programs
• Build utilities in support of other programming tasks
• Follow all standard templates to create, validate and review internal documents
• Present in all required meetings
• Lead programming activities based on management request
• Submit timesheet on requested time-period
• Mentor new-joiner or junior candidates on management request
• Ability self-learn and technical leadership is much preferred
• Design and/or provide input to new tools or review existing tools and improve where needed
• Proactively provide input to enhance the existing workflow, macros or tools for greater efficiency
• Provide input and efforts constantly update existing documents, macro programs and other workflows to cater ever changing requirement of CDISC standards