ADaM Subject Matter Expert – Contract

About the Role

This is senior level position and requires extensive and deep understanding of CDISC ADaM standards and related documents. You will be responsible to drive CDISC ADaM specification enhancement which supports metadata creation for both datasets and define.xml. In addition to this, the position requires to up version all ADaM related documentation and maintaining them as and when new standards are available. We are looking for a candidate who will draft all ADaM standards related document and put them into standard practice within organization and be a Subject Matter Expert (SME) for internal support and any client requirement. This position also requires to lead initiative of creating macro ecosystem to generate component of ADaM datasets and related automation. You also be participating in the creating TFL level metadata and TFL macro ecosystem at a later stage. Ideal candidate should be very independent person, highly proactive and communicative.

Qualifications

• At least 9+ years of experience in CDISC ADaM datasets and TFL generation in either Sponsor or CRO side
• At least 6+ years of experience in CDISC ADaM standard implementation, maintenance, and development
• 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
• Strong SAS Macro programming expertise needed
• Excellent written and verbal communication skills
• Ability to read, write, speak, and understand English
• Basic understanding of the clinical research domain

Responsibilities

• Review ADaM specifications and their define package
• Create and maintain standard ADaM machine-readable specification template to use for a wider programming community
• Maintain and up-version ADaM specification to meet ever changing CDISC ADaM standards
• Create and maintain supporting documentation for define.xml guidance
• Create and maintain a standard repository of internal automated checks to be performed on Specification metadata, datasets and define.xml
• Provide input to the study team on extensive ADaM standard-related questions and assist them throughout the study conduct cycle
• Create and maintain general guidance on ADaM dataset structure and related creation flow
• Create and maintain a standard list of ADaM QC checklists for delivery
• Create and maintain the TFL shell annotation standard document and assist in the up-versioning of the document
• Create, maintain, and provide input to SAS Macro to enable the creation of ADaM datasets based on specification metadata
• Create, maintain, and provide input to utilitarian SAS Macro to enhance the overall ADaM workflow
• Create, maintain, and provide input to the ARS process
• Create, maintain, and provide input to reporting-level standard modular macros
• Create, validate, and review CDISC ADaM datasets
• Create and review CDISC ADaM define package and specification