Principal Statistical Programmer

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 in independently with minimum guidance
Able to work in 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 members.
Learn new skills as needed
Good Communication skills

Education/Experience:

• Bachelors or Master in Statistics, computer science or analytical field with 5+ year experience in CRO/Pharma or Biotech industry
• Experience in Oncology domain a plus
• 7 + year of Statistical programming experience
• CDISC (SDTM , ADaM) experience a must
• Good oral and written communication skills