SDTM/ADaMModel and IG

Thoroughunderstanding of SDTM/ADAM concepts and challenges. Good hold on the TAUGs andrelated guidelines. Hands on experience in implementing SDTM/ADAM conceptsacross TAs and various phases of clinical trains. Good understanding onprevious versions on SDTM/ADAM guidelines.

StudyReporting
Suggest creative solutionapproach for various business requirements to solve complex SDTM/ADaM Mappingand Programming problems (e.g. creates modular reusable code, develops standardcode or utilities, and designs interconnected programs. Review and authordocuments related to deliverables (User Guide, CDARS Mapping Specification,OCF, Test Plans,

SAS Logs andPrograms). Good understanding of all study documents including Protocol, SAP,Mock Shells, LOT, Analysis plan etc. Hands on experience of development andreview of study specific tables, listings and figures for various phases ofclinical trials and across TAs.

SASProgramming

Expertise in Baseand Advance SAS programming. Expertise in developing macros and developinggeneralized programs. Development of the complex SAS macros that can beutilized across TAs in multiple studies; review of the developed SAS programs.Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS and other advanced SAS components. Mentor andsupervise developer to build generic standard macros, generic listings or otherad-hoc requests in accordance with business requirements.

ControlledTerminology

Goodunderstanding of code list and value list concepts. Expertise in managing NCIcodelist and tracking its updates. Exposure to CDASH, SDTM/ADaM and ADaMlineage concepts

1. Statistical Programmer lead should work on complex problems inwhich analysis of situations or data requires an in-depth evaluation of variousfactors, exercises judgment within broadly defined practices and policies inselecting methods, techniques an d evaluation criteria for obtaining results,and may determine methods and procedures on new assignments and may provideguidance to other lower level personnel.

2. Serve as leadprogrammer and use professional concepts in accordance with company objectivesto solve complex problems in creative and effective ways for one or moreclinical studies.

Review documents related to deliverables(Pinnacle 1. report, esubdocuments)

2. Suggestimprovements for delivering outputs and co-ordinate work on multiple projectsbased on priority.

3. Author the ADAMMapping specifications for Safety and Efficacy domains.