Statistical Programmer Lead

SDTM/ADaM Model and IG

Thorough understanding of SDTM/ADAM concepts and challenges. Good hold on the TAUG's and related guidelines.

Hands on experience in implementing SDTM/ADAM concepts across TA's and various phases of clinical trains. Good understanding on previous versions on SDTM/ADAM guidelines.

Study Reporting

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

SAS Logs and Programs). Good understanding of all study documents including Protocol, SAP, Mock Shells, LOT, Analysis plan etc. Hands on experience of development and review of study specific tables, listings and figures for various phases of clinical trials and across TA's.

SAS Programming

Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs.

Development of the complex SAS macros that can be utilized 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 and supervise developer to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements.

Controlled Terminology

Good understanding of code list and value list concepts. Expertise in managing NCI codelist and tracking its updates. Exposure to CDASH, SDTM/ADaM and ADaM lineage concepts

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

2.Serve as lead programmer and use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways for one or more clinical studies.

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

2.Suggest improvements for delivering outputs and co-ordinate work on multiple projects based on priority.

3.Author the ADAM Mapping specifications for Safety and Efficacy domains.