Naresh Ch

Aspiring leader with 10+ years of experience in SAS Programming and managing Programming Teams. 

As a programming Lead, responsible for managing a team of 5 highly skilled programmers at Individual contributor levels. experience on generating Tables, Listings and Graphs. Involved in production and validation of SDTM and ADAM datasets, specifications as per CDISC standards. Prepared define.xml, SDRG and ADRG as per client and Pinnacle 21 validation. As a programming leadership team (LT) member, contributes to resourcing strategies, talent management and initiatives. Accountable for delivery of programming activities for key assets. 

• Perform and oversee project team in all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity.
• Lead design/development of SAS macros and other utilities to expedite SAS programming activities.
• Organize and conduct internal training sessions and mentoring to Study Programming team members and FSP group.
• Work with CRO counterpart on project timeline management; oversee and provide input on statistical programming activities, ensure timely and quality delivery.
• Develop or review SDTM aCRF and specifications, ADaM specifications, complete programming and validation of CDISC SDTM and ADaM datasets.
• Generate tables, listings, and figures using SAS/BASE, SAS/GRAPH and SAS/STAT
• Act as a Programming SME for assigned studies, including authoring/reviewing programming specifications, such as SDTM/ADaM specifications, TFLs creation and QC for reporting events, eSUB packages, and documenting production and validation programs as per protocol, Statistical Analysis Plan, and/or approved client request.
• Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines. Develop define.xml, study data reviewers guide and analysis datasets reviewers guide

Master's in Clinical research and Regulatory affairs