Senior Quantitative Analyst

5 days ago

Dombivli, Maharashtra, India beBeeStatistical Full time ₹ 15,00,000 - ₹ 25,00,000

Job Overview

This is a statistical programmer position that provides lead support for multiple clinical research study projects or study teams.

The successful candidate will develop and implement statistical programming methodologies using SAS (Base and Macros) for clinical projects across the organization.

The primary focus will be on ensuring sound methodologies are adopted by establishing proficiency of programming techniques required for clinical trials research, including CDISC standards and analysis data sets.

The role requires delivering key regulatory-compliant output based on established proficiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.

Key Responsibilities:

  • Develop programming documentation and annotations, including specifications, review of mock shells, adhering to relevant Standard Operating Procedures.
  • Write well-documented, efficient, and high-quality code, conduct code review, and support cross-functional programming activities as needed.

Requirements and Qualifications

  • A bachelor's degree in a scientific discipline plus 4 years of statistical programming experience as a CDISC/TLF Statistical programmer in Pharmaceutical/CRO environment.
  • Understanding of GCP principles and other regulatory standards (e.g. FDA, EMA, and ICH guidance and recommendations) in Clinical Research.
  • Good analytical skills with the ability to process scientific and medical data.
  • Strong statistical programming skills in SAS, familiarity with R, Python, or other relevant statistical software is beneficial.

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