Senior Manager of Statistical Programming

3 days ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

About the Role

Bristol Myers Squibb is seeking a highly skilled Senior Manager of Statistical Programming to join our team. This is a critical role that requires expertise in statistical programming, data analysis, and project management.

Key Responsibilities:

  • Provide comprehensive programming leadership and support to clinical project teams and vendors.
  • Develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
  • Lead or support the electronic submission preparation and review.
  • Develop unambiguous and robust programming specifications.
  • Review key planning documents to align with project objectives and ensure clarity and completeness of programming assumptions and requirements.
  • Communicate proactively and effectively around issues and risks, and contribute to their remediation.

Requirements:

  • Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required.
  • At least 8 years of programming experience in industry, including support of significant regulatory filings.
  • Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
  • Broad expertise in statistical programming and in developing computing strategies.
  • In-depth understanding of clinical data structure and relational databases.
  • Demonstrated proficiency in using SAS and other software tools and applications.
  • Demonstrated ability to work in a team environment with clinical team members.

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