Statistical Programming Director Lead

3 days ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time
Transforming Patients' Lives Through Science

Bristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science.

About the Role

We are seeking an experienced Associate Director, Statistical Programming, to provide functional expertise and leadership to clinical project teams.

This role involves designing, developing, and implementing technical solutions for integrating, analyzing, and reporting clinical data.

The successful candidate will drive the development and implementation of innovative strategies and technologies for clinical trial programming.

In this position, you will lead improvement initiatives, independently plan, implement, and identify issues/risks, and provide remediation strategies to facilitate decision making.

Key Responsibilities
  • Provides comprehensive programming leadership and support to complex clinical project teams and vendors.
  • Drives the development and implementation of innovative strategies and technologies for clinical trial programming.
  • Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards.
  • Leads the electronic submission preparation and review.
  • Develops unambiguous and robust programming specifications (e.g., ADaM specifications).
  • Reviews planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities.
Requirements
  • Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required.
  • At least 10 years programming experience in industry, including support of significant regulatory filings, and minimum 5 years of experience in managing technical professionals in a regulated environment.
  • 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 (e.g., CDISC standards) and relational databases.
  • Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g., MS office, XML, Pinnacle 21).
  • Demonstrated ability in processing of upstream data (e.g., multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements (e.g., ADaM, TFLs, e-submission components).
  • Demonstrated ability to work in a team environment with clinical team members.
What We Offer

Bristol Myers Squibb offers a competitive salary of $175,000 - $225,000 per year, depending on experience.

As an Associate Director, Statistical Programming, you will have opportunities for professional growth and development in a dynamic and inclusive work environment.

Our company values innovation, urgency, accountability, inclusion, and integrity.

We offer a range of benefits, including health insurance, retirement savings plans, and paid time off.

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