Clinical Statistical Programmer Lead

Medtek is growing data science driven company to support faster drug development and healthcare solutions.

ESSENTIAL DUTIES AND RESPONSIBILITIES OF PRINCIPAL STATISTICAL PROGRAMMER-

Independently lead statistical programming activities for Phase 1/2/3 studies

Create SDTM Spec and program and validate SDTM datasets

Create ADaM Spec and program and validate ADaM datasets

Create Safety and Efficacy Tables, Listing and Graphs

Review Pinnacle 21 reports.

Debug macros and create study specific macros if needed.

Deliver good quality regulatory outputs for FDA/EMA and other submissions

Able to program and deliver independently with minimum guidance

Able to work in a multitasking environment and lead studies

Pay attention to details and provide timely updates.

Provide technical guidance to other statistical programmers and ensure training and development of team memb...