Principal Quantitative Analyst

2 weeks ago

Hyderabad, Telangana, India beBeeStatistical Full time ₹ 15,00,000 - ₹ 22,00,000
Job Title

Senior Statistical Programmer

This is a highly specialized role that requires extensive knowledge of statistical programming and SAS. The successful candidate will provide lead statistical programming support for multiple clinical projects, ensuring the adoption of sound methodologies and proficiency in programming techniques required for clinical trials research.

Key Responsibilities:
  • Lead Statistical Programming Support: Provide expert consultation to projects across the company, including statistical programming methodology, regulatory requirements, and compliance with CDISC standards.
  • Statistical Programming Development: Develop high-quality code, conduct code review, and support cross-functional programming activities.
  • Regulatory Compliance: Ensure deliverables are based on established proficiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.
  • Programming Documentation: Develop and maintain programming documentation, annotations, and specifications adhering to relevant Standard Operating Procedures.
  • Mentorship and Training: Mentor staff on statistical programming techniques and ensure they adopt sound methodologies.
Required Skills and Qualifications:
  • Education: A bachelor's degree plus 4 years' experience as a CDISC/TLF Statistical programmer in Pharmaceutical/CRO environment, education in a scientific discipline preferred.
  • Skills: Strong analytical skills, ability to process scientific and medical data, understanding of GCP principles and other regulatory standards (e.g. FDA, EMA, ICH guidance and recommendations).
  • Software Proficiency: Expertise in SAS, familiarity with R, Python or other relevant statistical software beneficial.
Benefits:

The ideal candidate will be motivated by the opportunity to work with cutting-edge technology and make meaningful contributions to the development of new treatments.

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