Senior Statistical Programmer

15 hours ago

Noida India MEDTEK AI Full time

Job Description

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 programand 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 multitask and work in a matrix environment

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

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

Bachelors or Master in Statistics, computer science or analytical field with 6+ 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

Job Type: Full-time

Pay: 25-30 Lacs P.A.

Schedule:

8 hour shift

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