Senior Statistical Programming Manager

3 weeks ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

Transforming Patients' Lives through Science

Bristol Myers Squibb is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that improve patients' lives. We are seeking an experienced Associate Director, Statistical Programming, to join our team and contribute to the development of life-changing treatments.

As an Associate Director, Statistical Programming, you will provide functional expertise and leadership to clinical project teams, driving the design, development, and implementation of technical solutions for integrating, analyzing, and reporting clinical data. You will also develop and implement innovative strategies and technologies for clinical trial programming, collaborating with cross-functional teams to ensure seamless execution.

Key Responsibilities:

  • Provides comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices.
  • 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.

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