Sr. Projects Lead, Data Standards and SDTM Delivery

Key Responsibilities::

Involves in the development, validation, and review of study & standard programs/macros (Including SAS, CQL, PL/SQL, SPOTFIRE, R-Programming, Python) that support standard and study-level conversion of clinical trial data.
Responsible for the review, development, and validation of SDTM mapping, aCRF, SDRG (Study Data Reviewers Guide), Pinnacle 21, define.xml, data Listings and checks for various standard or specific studies.
Leads the Requirement gathering, development of specifications, validation plans and performing end to end validation of Standard/Study macros.
Implements defensive programming techniques as a part of development lifecycle management of macros/programs/tools.
Project Manages end to end study and ensures deliverables are met on time.
Handles end to end studies (CDM (Clinical Data Management) To Submission).
Support the programmers in troubleshooting and debugging of complex standard and stu...