Statistical Programming Director

5 days ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time
About BMS

Bristol Myers Squibb is a pioneering organization dedicated to delivering cutting-edge treatments for serious diseases. Our integrated global hub in Hyderabad serves as a focal point for innovative solutions, combining science, technology, and innovation to create sustainable results.

Job Summary

We are seeking an experienced Senior Manager of Statistical Programming to join our team at Bristol Myers Squibb. This key role involves providing comprehensive programming expertise to clinical project teams, leading statistical programming teams, and supporting the development, regulatory approval, and market acceptance of our products.

Key Responsibilities
  1. Provide strategic guidance on programming strategies, standards, specifications, and analysis to ensure compliance with regulatory requirements, SOPs, and work practices.
  2. Develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
  3. Lead or support the electronic submission preparation and review process.
  4. Create robust programming specifications, including ADaM specifications, to ensure data integrity and accuracy.
  5. Evaluate and align key planning documents (statistical analysis plan, data presentation plan, data review plan) with project objectives to guarantee clarity and completeness of programming assumptions and requirements.
  6. Proactively communicate around issues and risks, contributing to their remediation.
Requirements and Qualifications

This role requires a Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences, along with at least 9+ years of industry experience, including significant regulatory filing support. Proficiency in drug development processes, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data is essential. Strong expertise in statistical programming and computing strategy development is also necessary.

A solid understanding of clinical data structure, relational databases, and proficiency in using SAS to produce analysis datasets and TFLs, as well as other software tools and applications, are required. Experience working in Therapeutic areas like Oncology, Immunology, Hematology, and Medical Affairs is highly desirable.

Estimated Salary

$145,000 - $185,000 per year, depending on location and experience.



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