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-

Independentlyleadstatistical 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 members.

Learn new skills as needed

Good Communication skills

Education/Experience:

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