Senior Programming Lead

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 study programs / macros.

Acts as a technical owner and / or reviewer / approver for tools and programs developed in the group.

For complex programs & tools, oversee & coordinate a group of Programming in a matrix setting.

Establish and maintain effective working relationships with partners and stakeholders while assisting them through progress and challenges with deliverables.

Adhere to the relevant departmental SOPs (Standard Operating Procedures), corporate policies, regulatory requirements, and industry best practices.

Adhere to standards and aware of industry standards and updates.